CDSCO risk classification
Ophthalmology medical device classification
Every ophthalmology device in CDSCO's classification register, with its risk class under the Medical Devices Rules, 2017 and its intended use. 76 are Class A non-sterile, non-measuring devices, which are exempt from licensing but must be registered.
- Devices
- 185
- Class A
- 109
- Class B
- 34
- Class C
- 37
- Class D
- 4
Ophthalmology devices and their class
185 devices
Adaptometer
Ophthalmology
Class BAn ophthalmic device intended to measure the time required for retinal adaptation and the minimum light threshold.
Amsler grid
Ophthalmology
Class ANon-sterile, non-measuringAn ophthalmic device intended to rapidly detect central and paracentral irregularities in the visual field.
Anomaloscope
Ophthalmology
Class ANon-sterile, non-measuringA ophthalmic instrument used to test a patient for abnormal red/green colour vision by differentiating the red/green colour vision defects.
Anterior chamber physical simulator
Ophthalmology
Class ANon-sterile, non-measuringA non-powered, non-patient-contact device intended to mimic the fluid dynamics in the anterior chamber of the eye during priming/calibration of a phacoemulsification system irrigation/aspiration pump (not included).
Aqueous/vitreous humour replacement medium kit
Ophthalmology
Class DA collection of sterile devices, including a fluid or semifluid substance, used in combination to replace the fluid of the eye.
Automated lensmeter(Dioptometer)
Ophthalmology
Class AAn ophthalmic instrument designed to measure the focusing power (dioptric power) and other optical characteristics of a spectacle lens, contact lens, or prism.
Bagolini lens
Ophthalmology
Class AAn ophthalmic plane lens, intended to determine harmonious/anomalous retinal correspondence.
Bagolini lens/Bagolini striated glasses
Ophthalmology
Class ANon-sterile, non-measuringIntended to determine harmonious/anomalous retinal correspondence.
Balloon Catheter for Retinal Reattachment
Ophthalmology
Class BAn instrument for reattachment of a detached retina to the inner wall of the eyeball. It can be inserted into the interior of the eyeball.
Binocular indirect lenses
Ophthalmology
Class ANon-sterile, non-measuringIntended for visualization of the human retina (fundus) using a binocular indirect ophthalmoscope.
Binocular vision test unit
Ophthalmology
Class AAn ophthalmic device for binocular vision testing.
Blepharoplasty scissors
Ophthalmology
Class AA hand-held, manual, ophthalmic surgical instrument intended to be used to cut eyelid tissue during plastic surgery of the eyelids (blepharoplasty).
Capsular bag anchor
Ophthalmology
Class CA device intended to be permanently implanted in the posterior chamber of the eye for correction and fixation of a subluxated capsular bag, typically in association with in-the-bag intraocular lens (IOL) implantation.
Cerebral Cavernous Malformations (CAM) vision stimulator
Ophthalmology
Class ANon-sterile, non-measuringIntended for stimulation of the eye for treatment of lazy/ambyopic eye.
Cilia forceps
Ophthalmology
Class ANon-sterile, non-measuringA hand-held, manual, surgical instrument intended to facilitate the grasping and removal of the cilia (eyelashes). This is a reusable device intended to be sterilized prior to use.
Colour discrimination non- prescription spectacles
Ophthalmology
Class ANon-sterile, non-measuringAn ophthalmic device intended for use by people with color blindness to improve color discrimination and may also block UVA and UVB radiation from sunlight.
Colour discrimination tester
Ophthalmology
Class ANon-sterile, non-measuringAn ophthalmic lamp, used to test a person's ability to differentiate between colours.
Colour-discrimination eye chart
Ophthalmology
Class ANon-sterile, non-measuringIntended for testing colour vision.
Conjunctival scissors
Ophthalmology
Class AA hand-held, manual, ophthalmic surgical instrument intended to be used to cut the conjunctiva and Tenon’s capsule on the eye surface to access the sclera.
Contact Lens (Including Coloured Contact Lens)
Ophthalmology
Class BDevice intended to be worn directly against the cornea and adjacent limbal and scleral areas of the eye to correct vision conditions or act as a therapeutic bandage or/and to change the appearance of the eye for decorative purposes.
Contact lens agitation cleaning system
Ophthalmology
Class BAn assembly of devices used to clean and disinfect contact lenses through automated or manual mechanical agitation .
Contact lens disinfecting solution
Ophthalmology
Class BAn aqueous formulation containing appropriate agents for loosening debris from contact lenses, and that contains a disinfectant intended to act on contact lens.
Contact Lens Inserter/Remover
Ophthalmology
Class AA device designed to insert and remove contact lenses from the eye.
Contact lens inserter/remover, non-sterile
Ophthalmology
Class ANon-sterile, non-measuringIntended to insert and remove contact lenses from the eye. It does not come in direct contact with the eyeball. This is a reusable device.
Contact lens protein-removal solution
Ophthalmology
Class BA formulation of proteolytic enzymes, used to remove debris and protein deposits from reusable contact lenses, or to remove protein deposits only.
Contact lens radius gauge
Ophthalmology
Class AA measuring instrument used in ophthalmology to determine the radius of curvature of contact lenses.
Contact lens thermal cleaner
Ophthalmology
Class BA unit intended to disinfect or sterilize reusable soft contact lenses by means of heat.
Corneal burr manual instrument
Ophthalmology
Class BA hand-held, ophthalmic surgical instrument, used to excavate corneal tissue through manual rotation.
Corneal burr system
Ophthalmology
Class BAn assembly of devices designed for abrasion of the cornea and other eye tissues.
Corneal burr, abrasion
Ophthalmology
Class BA device designed for abrasion of the cornea to polish corneal scratches and/or the pterygium bed after surgical removal, and/or for abrasion of lid margin lesions.
Corneal burr, rust ring removal
Ophthalmology
Class BA device designed for gentle removal of rust stains (rust rings) from the cornea after the extraction of a ferrous foreign object.
Corneal epithelium perforator
Ophthalmology
Class BIntended to create a number of small perforations in the epithelial layer of the cornea through which riboflavin can pass into the cornea during corneal collagen crosslinking, to treat corneal ectasia (typically keratoconus).
Corneal epithelium trephine
Ophthalmology
Class BIntended to create a circular cut through the epithelial layer of the cornea to create an epithelial flap intended to be folded back during laser assisted epithelial keratomileusis (LASEK) surgery, after which the flap is replaced.
Corneal inlay, aperture reducing
Ophthalmology
Class CA implantable device inserted into the natural cornea to treat presbyopia based on aperture reduction.
Corneal inlay, cornea- reshaping
Ophthalmology
Class CA implantable device inserted into the natural cornea to treat refractive errors by reshaping the cornea.
Corneal light shield
Ophthalmology
Class BA device, typically made of a non- abrasive fluid-absorbing material that is placed on the surface of the cornea to shield the retina from excessive illumination during an ophthalmic procedure.
Corneal marker
Ophthalmology
Class BA manual instrument intended to be used to imprint, indent, and/or incise corneal tissue prior to an ophthalmic surgical procedure.
Corneal resection holder
Ophthalmology
Class BA device designed to hold donated corneal tissue so that it can be resected in preparation for transplantation.
Corneal scissors
Ophthalmology
Class BA hand-held, manual, ophthalmic surgical instrument intended to be used to cut corneal tissue.
Corneal shield
Ophthalmology
Class BA mechanical eye shield made of collagen that is placed on the eye to protect the cornea.
Corneoscleral punch
Ophthalmology
Class BA hand-held, manual ophthalmic surgical instrument designed to excise a segment of tissue from the sclera or cornea of a patient or from grafts taken from cadaver donors.
Diagnostic condensing lens
Ophthalmology
Class ANon-sterile, non-measuringAn ophthalmic lens used in binocular indirect ophthalmoscopy to focus reflected light from the fundus of the eye.
Direct ophthalmoscope eye cup
Ophthalmology
Class ANon-sterile, non-measuringThe device is intended to be attached to the distal (patient-contact) end of a direct ophthalmoscope head to facilitate appropriate positioning around the patient’s eye socket during an examination.
Donor cornea container
Ophthalmology
Class CA receptacle intended to maintain, transport, and facilitate clinical examination of a donated cornea during the period between cornea collection and transplantation surgery.
Eikonometer
Ophthalmology
Class AAn ophthalmic instrument for diagnosing aniseikonia.
Electronic occlusion spectacles
Ophthalmology
Class ANon-sterile, non-measuringAn ophthalmic device designed to test and train vision for conditions where decreased visual acuity may be due to unequal vision in the eyes.
Endoscopic-imaging ophthalmic solid-state laser system
Ophthalmology
Class CA device assembly intended to treat retinal and other eye disorders, such as glaucoma, during endoscopic cyclophotocoagulation (ECP) procedures.
Enucleation scissors
Ophthalmology
Class AA hand-held, manual, ophthalmic surgical instrument used to cut tissue during eye surgery involving enucleation of the eye and/or its related structures.
Epiretinal/inner limiting membrane scraper
Ophthalmology
Class BA hand-held manual surgical instrument intended to be used during posterior segment surgery to lift the inner limiting membrane (ILM) and/or an epiretinal membrane (ERM), and which may have additional posterior segment membrane manipulation uses.
Euthyscope
Ophthalmology
Class ANon-sterile, non-measuringA modified ophthalmoscope that projects a bright light encompassing an arc of approximately 30 degrees on the fundus of the eye for the treatment of amblyopia.
Exophthalmometer
Ophthalmology
Class AAn ophthalmic instrument used to measure the degree of exophthalmos.
Eye cup
Ophthalmology
Class ANon-sterile, non-measuringA receptacle designed to fit around the eye socket and which is filled with warm water or an eyewash solution and placed over the eye to allow the liquid to wash the affected eye.
Eye heat therapy mask, self- heating, single-use
Ophthalmology
Class ANon-sterile, non-measuringA non-sterile, self-heating device intended for delivering moist heat to the eyes for relief in dry eyes syndrome, fatigue, soreness, meibomian gland function, etc.
Eye heat therapy pack
Ophthalmology
Class BA device intended to be placed over closed eyes to apply heat for the treatment of meibomian gland dysfunction (MGD), dry eye syndromes, blepharitis and other related ocular conditions.
Eye irrigation shield
Ophthalmology
Class ANon-sterile, non-measuringA device intended to be used with an eye irrigation kit/system to direct irrigation solution to the surface of the eye and allow the solution to gently lavage the surface of the eye.
Eye muscle clamp
Ophthalmology
Class BAn hand-held manual ophthalmic surgical instrument designed to atraumatically grasp and hold the extraocular muscles (EOM) during an ophthalmic surgical intervention.
Eye muscle sleeve
Ophthalmology
Class CAn implantable device made from synthetic materials that is used to encase or isolate an ocular muscle.
Eye pad
Ophthalmology
Class AA sterile, cushion-like device intended to protect the eye or to absorb eye secretions.
Eye pad, non sterile
Ophthalmology
Class ANon-sterile, non-measuringIntended for use as a bandage over the eye for protection or absorption of secretions.
Eye patch, non-sterile
Ophthalmology
Class ANon-sterile, non-measuringA device with a synthetic origin used to close/cover one or both eyes, for the purpose of protecting the eye after a procedure or as part of an ophthalmic therapeutic intervention or as a occluder for vision or field testing.
Eye sphere implant
Ophthalmology
Class DAn eye sphere implant is a device intended to be implanted in the eyeball to occupy space following the removal of the contents of the eyeball with the sclera left intact.
Eye spud
Ophthalmology
Class AA hand-held, manual, ophthalmic surgical instrument intended to be used to remove a foreign body/object embedded in or adhering to the surface of the eye globe.
Eye valve
Ophthalmology
Class CAn implantable device designed to regulate the flow of fluid between the anterior chamber and the space around the conjunctiva of the eye by allowing flow when the pressure in the chamber is above a pre-set value.
Eyelid clamp
Ophthalmology
Class AA hand-held manual surgical instrument designed to atraumatically grasp and hold the eyelid during an ophthalmic surgical intervention.
Eyelid clamp, reusable
Ophthalmology
Class ANon-sterile, non-measuringA hand-held manual surgical instrument intended to atraumatically grasp and hold the eyelid during an ophthalmic surgical intervention. This is a reusable device.
Eyelid speculum, reusable
Ophthalmology
Class ANon-sterile, non-measuringA self-retaining, ophthalmic surgical instrument intended to be used to retract the eyelids during an opthalmologic examination or procedure. This is a reusable device.
Eyelid weight, external
Ophthalmology
Class ANon-sterile, non-measuringAn ophthalmic device that is applied to the outside of the upper eyelid to "lidload" the eyelid to restore upper eyelid muscle function.
Eyelid weight, implantable
Ophthalmology
Class CAn ophthalmic device that is implanted subcutaneously within the upper eyelid to "lidload" the eyelid to restore upper eyelid muscle function.
Felt tangent screen
Ophthalmology
Class ANon-sterile, non-measuringA black tangent screen intended for assessing the extent of the patients peripheral visual field by mapping the visual response to a test object moved from the periphery towards the centre of the screen.
Femtosecond ophthalmic solid-state laser system
Ophthalmology
Class CA device assembly in which input energy is used to excite a glass/crystal rod to emit a high-power laser beam intended for ocular resections and incisions.
Fibreoptic general-purpose ophthalmic hook
Ophthalmology
Class AA hand-held manual surgical instrument inserted into the eye during surgical intervention to manipulate anatomical structures or foreign bodies within the eye and simultaneously conduct a field of cold light to illuminate the surgical site.
Flieringa ophthalmic ring
Ophthalmology
Class ANon-sterile, non-measuringA circular band, sutured to the sclera to prevent collapse of the globe during difficult intraocular operations.
Fornixscope
Ophthalmology
Class ANon-sterile, non-measuringA manually-operated, ophthalmic device intended to provide indirect access and viewing of the upper conjunctival fornix and inner surface of the eyelid as an alternative to eyelid eversion.
Fresnel lens
Ophthalmology
Class ANon-sterile, non-measuringA very thin and flexible ophthalmic lens intended to be applied to the back of spectacle lenses to focus light to a focal point to help manage various vision conditions.
Fresnel prism
Ophthalmology
Class ANon-sterile, non-measuringA device intended to be applied to spectacle lenses to give a prismatic effect typically to manage strabismus or other eye muscle dysfunction.
Fundus camera
Ophthalmology
Class ANon-sterile, non-measuringIt is intended to capture and document digital images of the posterior and anterior segments of the human eye.
Fundus camera, pediatric
Ophthalmology
Class ANon-sterile, non-measuringIntended to capture digital color images of the retina of infants having less than 55 weeks of Post Menstrual Age (PMA), while their eyes are dilated using mydriatic drops under clinical control.
Fundus-imaging ophthalmic diode laser system
Ophthalmology
Class CIntended for: ocular laser treatment procedures, including coagulation of abnormal retinal vasculature and capturing real-time digital images of the anterior/posterior eye segments created using colour, fluorescein angiography and infrared imaging, for diagnosis/treatment planning.
Fundus-imaging ophthalmic solid-state laser system
Ophthalmology
Class CIntended to coagulate abnormal vascular tissue in the retina and for other ocular photocoagulation procedures.
Glaucoma supraciliary implant
Ophthalmology
Class CA non-bioabsorbable synthetic polymer device designed to be implanted in the supraciliary space (between the ciliary muscle/body and the sclera) for the restoration of aqueous humour outflow and subsequent reduction of intraocular pressure as part of treatment for open angle glaucoma.
Glaucoma therapy ultrasound system
Ophthalmology
Class CA system designed to transduce radio- frequency (RF) electrical energy from a generator into ultrasound energy, for the extracorporeal application of high intensity focused ultrasound (HIFU) to the eye, to decrease aqueous humour production and reduce intraocular pressure (IOP)
Gonio lens/ Gonioscope
Ophthalmology
Class ANon-sterile, non-measuringA hand-held device intended for viewing the anterior chamber angle and retina.
Haidinger brush imager
Ophthalmology
Class ANon-sterile, non-measuringAn ophthalmic device designed to produce an image which facilitates his/her visual function evaluation, particularly the macular integrity.
Hand-held campimeter
Ophthalmology
Class AA portable, hand-held device intended for assessing the central 30º visual field.
Hand-held telescope
Ophthalmology
Class ANon-sterile, non-measuringA device that consists of an arrangement of ophthalmic lenses or mirrors with a handle intended to enlarge images for a visually impaired patient/person.
Head reflector
Ophthalmology
Class ANon-sterile, non-measuringA head-worn device intended to reflect light to a site of examination/minor intervention (e.g., the nose, throat, or body surface) on a patient.
Hruby fundus lens
Ophthalmology
Class ANon-sterile, non-measuringA 55 dioptre non-contact diagnostic ophthalmic lens intended for use in the examination of the vitreous body and the fundus of the eye under slitlamp illumination and magnification.
Implantable intraocular pressure monitoring system
Ophthalmology
Class CAn assembly of portable devices intended to continuously or regularly collect and display intraocular pressure (IOP) data for the diagnosis/monitoring of glaucoma.
Implantable iris prosthesis
Ophthalmology
Class CAn optical device intended to be implanted into the posterior chamber of the eye for the reconstruction of partial or total iris defects.
Indirect binocular ophthalmoscope
Ophthalmology
Class ANon-sterile, non-measuringAn ophthalmic instrument designed to examine the interior of the eye allowing the examiner to clearly see a wide angle, stereoscopic impression of the details of the fundus (retina) and other structures.
Intracorneal ring
Ophthalmology
Class CAn implantable, open-ended circular band designed to flatten the anterior corneal curvature, without disturbing the visual axis, to correct mild and moderate myopia.
Intranasal lacrimal neurostimulator
Ophthalmology
Class CA hand-held device intended to be used in the home to provide electrical stimulation to sensory neurons of the nasal cavities to acutely increase tear production as treatment for aqueous deficient dry eye.
Intraocular fluid
Ophthalmology
Class CAn intraocular fluid is a device consisting of a nongaseous fluid intended to be introduced into the eye to aid performance of surgery, such as to maintain anterior chamber depth, preserve tissue integrity, protect tissue from surgical trauma, or function as a tamponade during retinal reattachment.
Intraocular gas
Ophthalmology
Class CAn intraocular gas is a device consisting of a gaseous fluid intended to be introduced into the eye to place pressure on a detached retina.
Intraocular lens
Ophthalmology
Class CIntraocular lens (IOL) are lens implanted in the eye used to treat cataracts or myopia.
Intraocular lens guide
Ophthalmology
Class BAn intraocular lens guide is a device intended to be inserted into the eye during surgery to direct the insertion of an intraocular lens and be removed after insertion is completed.
Intraocular pressure-reducing system
Ophthalmology
Class CAn assembly of manually-operated devices designed to reduce the intraocular pressure (IOP) by applying a controlled, external, mechanical compression to the surface of the eye in preparation for ophthalmic surgery.
Keratome
Ophthalmology
Class BAn ophthalmic surgical instrument intended to shave tissue from sections of the cornea for a lamellar (partial thickness) transplant.
Keratoprosthesis
Ophthalmology
Class DIt is a device intended to provide a transparent optical pathway through an opacified cornea, either intraoperatively or permanently, in an eye.
Keratoscope
Ophthalmology
Class BA keratoscope is an AC-powered or battery-powered device intended to measure and evaluate the corneal curvature of the eye. Lines and circles within the keratoscope are used to observe the corneal reflex. This generic type of device includes the photokeratoscope and videokeratoscope which records corneal curvature by taking photographs or videos of the cornea.
Lacrimal tube
Ophthalmology
Class CA implantable, single-lumen tube intended to provide tear drainage from the front surface of the eye, and also to facilitate saline solution irrigation to a paranasal sinus to manage chronic rhinosinusitis.
Lens spoon
Ophthalmology
Class AA hand-held ophthalmic surgical instrument used in ophthalmic surgery to manipulate/remove the lens of the eye.
Lens system, Ophthalmology, high magnification
Ophthalmology
Class ANon-sterile, non-measuringA device (lens) intended for use to observe the retina or anterior chamber of the eye.
Maddox trial lens
Ophthalmology
Class ANon-sterile, non-measuringA special ophthalmic trial lens in the form of a rod or series of rods (grooves/cylinders) that changes the size, shape, and colour of an image to dissociate the eyes in the evaluation of eye muscle dysfunction.
Medical Laser protection/safety eyewear
Ophthalmology
Class ANon-sterile, non-measuringIntended to be used by the staff in an operating or treatment room where a laser is being used, in order to protect their eyes from injury during the laser surgery.
Meibomian gland camera
Ophthalmology
Class ANon-sterile, non-measuringIt is an ophthalmic imaging device intended for use by a physician in adult patients to capture, archive, manipulate and store digital images of the meibomian glands.
Meibomian gland expressor/evaluator, manual
Ophthalmology
Class ANon-sterile, non-measuringA non-powered, hand-held manual ophthalmic instrument intended to be used to apply pressure to the lower eyelid to facilitate natural release and/or expression of meibomian gland secretions (meibum) to treat dry eye syndrome.
Mirror-prism spectacles
Ophthalmology
Class ANon-sterile, non-measuringAn optical device intended to enable the patient to see over the top of their head enabling them to look forward in the direction their head is pointing.
Needle holder, ophthalmology, reusable
Ophthalmology
Class ANon-sterile, non-measuringIt is intended to hold needle for procedure during eye surgeries. This is a reusable device intended to be sterilized prior to use.
Nystagmus inducing optokinetic drum
Ophthalmology
Class ANon-sterile, non-measuringAn ophthalmic device intended to elicit nystagmus.
Nystagmus inducing tape
Ophthalmology
Class ANon-sterile, non-measuringAn ophthalmic device intended to be moved across a patients field of vision to elicit optokinetic nystagmus and to test for blindness.
Ophthalmic calliper
Ophthalmology
Class AA hand-held manual ophthalmic measuring instrument consisting of two legs hinged at one end and designed to measure the diameter, length, angles, and thicknesses of the eye.
Ophthalmic clip
Ophthalmology
Class CA device typically made of a malleable metal (e.g., tantalum), intended to be implanted permanently or temporarily to bring together the edges of a wound, to aid in healing or to prevent bleeding from small blood vessels in the eye.
Ophthalmic cryosurgical system
Ophthalmology
Class CAn assembly of devices designed to apply cold from a gaseous or liquid refrigerant (cryogen) to a target tissue for its destruction and removal during an ophthalmic surgical procedure.
Ophthalmic distometer
Ophthalmology
Class AAn ophthalmic instrument designed to measure the distance between the cornea and a spectacle or trial lens (vertex distance).
Ophthalmic dye laser system
Ophthalmology
Class CA laser device assembly intended to coagulate abnormal vascular tissue in the retina, and for other photocoagulation procedures in the eye.
Ophthalmic equipment stand
Ophthalmology
Class ANon-sterile, non-measuringIt is intended to hold and support ophthalmic equipment like slit lamp, keratometer, laser devices, etc. Ophthalmic instruments are not included.
Ophthalmic excimer laser system
Ophthalmology
Class CA laser device assembly intended for corneal ablation and other ophthalmologic procedures.
Ophthalmic head reflector
Ophthalmology
Class ANon-sterile, non-measuringA head-worn ophthalmic device intended to reflect light onto the eye of a patient to allow examination of the eye and its associated structures.
Ophthalmic implant handling forceps, reusable
Ophthalmology
Class ANon-sterile, non-measuringA reusable instrument intended to grasp and manipulate ophthalmic implants (excluding sutures) during a surgical procedure.
Ophthalmic Irrigation Solution (Balanced Salt Solution)
Ophthalmology
Class BIntended for the irrigation of the anterior chamber during cataract surgery and other intraocular or extraocular procedures or for the irrigation of the conjunctiva following application of fluoresceine or for moistening the corneal and conjunctival surface during laser treatment.
Ophthalmic noble gas laser system
Ophthalmology
Class CA laser device assembly intended to coagulate abnormal vascular tissue in the retina and for other photocoagulation procedures in the eye.
Ophthalmic operating table top
Ophthalmology
Class ANon-sterile, non-measuringA component of a modular operating table intended to provide support for and stabilization of the head of the patient (typically includes a headrest) and to help provide optimal access for the surgeon(s) during the intervention (e.g., by having a small-width table top and therefore a shorter stretch distance for the surgeon).
Ophthalmic refractometer
Ophthalmology
Class BAn ophthalmic refractometer is an automatic AC-powered device that consists of a fixation system, a measurement and recording system, and an alignment system intended to measure the refractive power of the eye by measuring light reflexes from the retina.
Ophthalmic soft-tissue surgical forceps
Ophthalmology
Class BA hand-held manual instrument designed to grasp and manipulate intraocular tissues during ophthalmic surgery (e.g., anterior segment surgery, vitreo-retinal procedures, iridectomy, capsulorhexis).
Ophthalmic surgery fluid collection bag
Ophthalmology
Class ANon-sterile, non-measuringA fluid collection bag connected to a surgical system (not included), intended to catch aspirated material during an ophthalmic surgical procedure.
Ophthalmic surgical device handling forceps
Ophthalmology
Class AA hand-held manual surgical instrument with blades designed to grasp and manipulate a nonimplantable invasive ophthalmic surgical device (e.g., ophthalmic cannula, handless iris retractor) and/or for ophthalmic suturing.
Ophthalmic surgical device handling forceps, reusable
Ophthalmology
Class ANon-sterile, non-measuringIntended to grasp and manipulate a nonimplantable invasive ophthalmic surgical device (e.g., ophthalmic cannula, handless iris retractor). This is a reusable device.
Ophthalmic suture scissors
Ophthalmology
Class AA hand-held, manual, ophthalmic surgical instrument intended to be used to cut suture during eye surgery.
Ophthalmic suture scissors, reusable
Ophthalmology
Class ANon-sterile, non-measuringA hand-held, manual ophthalmic surgical instrument intended to cut suture, typically during eye surgery. This is a reusable device. It is not intended to come in direct contact with the eyeball. This is a reusable device.
Ophthalmic tonometer
Ophthalmology
Class BAn ophthalmic, measuring instrument designed for determining the intraocular pressure (IOP).
Ophthalmic Trial frame
Ophthalmology
Class ANon-sterile, non-measuringA device intended for use in ophthalmic work for holding trial lenses in front of the eyes during the sight-testing procedure.
Ophthalmic ultrasound imaging system
Ophthalmology
Class BAn assembly of devices designed for ophthalmic ultrasound imaging procedures.
Ophthalmic Viscosurgical Device
Ophthalmology
Class CViscoelastic solution for Intraocular use during eye surgery.
Ophthalmic working-channel cannula
Ophthalmology
Class BA rigid tube designed to create a channel through the sclera for internal ocular access during posterior segment ophthalmic surgery. It is typically made of plastic materials or high-grade stainless steel and enables the introduction of ophthalmic surgical instruments it may also be used for irrigation (i.e., the infusion of fluids to maintain the interior pressure of the eye during surgery). This is a reusable device.
Ophthalmodiastimeter
Ophthalmology
Class AAn ophthalmic instrument for determining the proper distance at which to place prescription lenses for the two eyes.
Ophthalmoleukoscope
Ophthalmology
Class ANon-sterile, non-measuringAn ophthalmic device intended to be used for testing colour perception by means of colours produced by polarized light.
Ophthalmoscope
Ophthalmology
Class BAn ophthalmic instrument designed to examine the interior of the eye allowing the examiner to clearly see the details of the retina and other structures/media.
Opthalmic examintaion station, without surgical unit
Ophthalmology
Class ANon-sterile, non-measuringA device assembly intended to provide complete ophthalmic examination position and support conditions for the patient and clinician. This does not include any diagnostic/surgical instruments.
Optical pachymeter
Ophthalmology
Class AAn ophthalmic, device that uses optics to measure the thickness of the cornea.
Orbital depressor
Ophthalmology
Class AA hand-held ophthalmic surgical instrument used to displace tissue to facilitate examination of the surrounding area in the orbital cavity during eye surgery.
Orbital depressor, reusable
Ophthalmology
Class AA hand-held ophthalmic instrument intended to be used for extra-orbital displacement of the sclera to facilitate examination/treatment of the surrounding area in the orbital cavity during eye surgery; it does not provide illumination.
Class taken from Merged existing medical devices risk classification, entry Ophthalmology 100 (Orbital depressor), because the register feed omits it.
Orbital rim prosthesis
Ophthalmology
Class CAn implantable ocular device used to reconstruct the floor of the bony cavity that contains the eyeball and its associated muscles, vessels, and nerves and is intended to house an artificial eye.
Perimeter
Ophthalmology
Class AA diagnostic, ophthalmic instrument intended for assessing the extent of the patients peripheral visual field.
Periocular/lacrimal retractor
Ophthalmology
Class AA hand-held, non-self-retaining, ophthalmic surgical instrument intended to be used to separate periocular tissues and/or draw aside the margins of a periocular surgical wound during an ophthalmic intervention.
Phacoemulsification system
Ophthalmology
Class CAn assembly of ophthalmic devices intended to deliver energy through a dedicated handpiece tip, which is introduced through an incision made in the lens capsule, to perform phacoemulsification.
Phorometer
Ophthalmology
Class AAn ophthalmic instrument intended to be used to test ocular balance.
Phoropter
Ophthalmology
Class AA mechanical ophthalmic device that is used during an ophthalmic examination; typically to determine a patients prescription for glasses.
Class taken from Merged existing medical devices risk classification, entry Ophthalmology 106, because the register feed omits it.
Phoropter arm
Ophthalmology
Class not statedIntended to mount the phoroptor during an ophthalmic examination; typically to mount the phoroptor to determine a patients prescription for glasses.
The class is missing from CDSCO's register data for this entry. Check the CDSCO register before relying on it.
Pleoptophor
Ophthalmology
Class ANon-sterile, non-measuringAn ophthalmic instrument used for the treatment of eccentric eye fixation (casts in the eye) by dazzling the perimacular retina, thereby relatively enhancing the visual capabilities of the fovea.
Polatest
Ophthalmology
Class ANon-sterile, non-measuringAn ophthalmic device used for evaluating hidden (latent) squinting, i.e., when the patient is not aware of the condition, and also when it cannot be seen.
Postsurgical transparent eye shield, vented
Ophthalmology
Class ANon-sterile, non-measuringA device intended to be worn over the eye to protect the eye while allowing the wearer to see, typically following ophthalmic surgery. It is designed as a transparent self-adhesive dome which includes vent holes to allow air to circulate around the eye. This is a single-use, non-sterile device.
Prefabricated/Mass- produced prescription spectacles
Ophthalmology
Class ANon-sterile, non-measuringA prefabricated ophthalmic device consisting of a spectacle frame with a pair of optical spectacle lenses (typically made of plastic or glass, also known as eyeglasses) intended to be worn over the eyes to provide refractive corrections to eyesight conditions such as presbyopia or refractive ametropia (myopia, hyperopia and astigmatism). The lenses may be tinted to protect the eyes from bright light and radiation.
Ptosis sling
Ophthalmology
Class CA sterile implantable device intended for the surgical correction of ptosis.
Pupillograph
Ophthalmology
Class ANon-sterile, non-measuringA graphic recorder used for recording the response of the pupil to reflected light. It is used for ophthalmic diagnostic purposes.
Pupillometer
Ophthalmology
Class AAn ophthalmic instrument used for measuring the width or diameter of the pupil.
Retinal implant
Ophthalmology
Class DThe retinal implant is meant to partially restore useful vision to people who have lost their vision due to degenerative eye conditions.
Retinal tack
Ophthalmology
Class CA non-bioabsorbable, implantable device designed to permanently fix a detached retina to the underlying retinal pigment epithelium (RPE) during ophthalmic surgery.
Scleral buckling device
Ophthalmology
Class CA device intended to be implanted on the sclera to compress the eye (scleral buckling) for the surgical treatment of retinal detachment.
Scleral expansion implant
Ophthalmology
Class CA device designed for implantation in the sclera to produce expansion by altering the position of the underlying ciliary muscle.
Scleral marker
Ophthalmology
Class BA manual instrument used to indent or imprint the surface of the sclera during an ophthalmic surgical or perioperative procedure.
Sclerotome
Ophthalmology
Class AA hand-held manual ophthalmic surgical instrument that is knife-like in design and intended to be used to incise the sclera during a sclerotomy.
Sclerotome, reusable
Ophthalmology
Class ANon-sterile, non-measuringA hand-held manual ophthalmic surgical instrument intended to be used to incise the sclera during a sclerotomy. This is a transient- use reusable device.
Scotometer
Ophthalmology
Class AAn instrument used for the recording and measuring of the areas of field of vision that is reduced, i.e., relative scotoma, or loss of sensitivity to light (absolute scotoma or blind spots).
Slit Lamp
Ophthalmology
Class ANon-sterile, non-measuringIntended to be used as a specialized magnifying microscope to examine the structures of the eye (including the cornea, iris, vitreous, and retina), without having a measuring function.
Strabismus ophthalmic hook/ Eye muscle hook, reusable
Ophthalmology
Class ANon-sterile, non-measuringA hand-held manual surgical instrument intended to be used to locate and hook extraocular muscles, typically during strabismus correction surgery. It is not designed for intraocular use. This is a reusable device.
Surgical binoculars
Ophthalmology
Class AA pair of lenses intended to be mounted onto a surgeon's spectacles to function as small telescope and provide a magnified image of the visual field during patient examination or surgical intervention.
Surgical eye pressure shield
Ophthalmology
Class ANon-sterile, non-measuringA non-sterile device intended to cover and mechanically protect the eyes of a patient during surgery to prevent potential ocular pressure hazards/injury associated with surgery (e.g., resulting from inadvertent pressure being applied to the eye by healthcare professionals, equipment, or due to the orientation of the patient).
Surgical lamp (ophthalmic)
Ophthalmology
Class ANon-sterile, non-measuringIntended to serve as a cold light source for illumination of the intraocular posterior segment in optical surgery in case of vitrectomies.
Symblepharon ring
Ophthalmology
Class CAn implantable device formed as a circular band used to help prevent the eyelid from adhering to the eyeball.
Synoptophor
Ophthalmology
Class ANon-sterile, non-measuringA ophthalmic device used for the evaluation and training of a patients binocular function.
Tachistoscope
Ophthalmology
Class ANon-sterile, non-measuringAn ophthalmic device designed to flash words or images at different speeds, for the purposes of ophthalmic diagnostic testing.
Tester, colour discrimination
Ophthalmology
Class ANon-sterile, non-measuringDevices intended for colour vision testing. This does not have a measuring function.
Ultrasound pachymeter
Ophthalmology
Class BAn ophthalmic device designed to use ultrasound to measure the thickness of the cornea, and may in addition be designed to measure axial length and anterior chamber depth.
Video indirect ophthalmoscope
Ophthalmology
Class ANon-sterile, non-measuringIntended as an illumination system to direct appropriately focused light into the eye in order to obtain an intermediate image of the fundus (retina) and record the images and videos of the patient.
Vision testing/training flipper
Ophthalmology
Class ANon-sterile, non-measuringA device in the form of flipper lenses (two lenses on either side of a rotatable stem) intended to be used for the diagnosis and treatment of ophthalmic accommodation disorders.
Vision training software
Ophthalmology
Class ANon-sterile, non-measuringA patient-interactive software package intended to use visual images (e.g., Gabor patch) to help improve vision based on noninvasive perceptual learning therapy (neuro-vision therapy), typically in patients with amblyopia, or who use corrective eyewear, or following ophthalmic surgery. This does not have a measuring function.
Visual chart
Ophthalmology
Class ANon-sterile, non-measuringAn ophthalmic chart (Snellen chart) used in testing visual .
Visual evoked-potential electrode
Ophthalmology
Class AAn electrical conductor intended to record changes in the electrical potential for the purpose of measuring visual evoked responses.
Visual field plotter
Ophthalmology
Class ANon-sterile, non-measuringDevice intended for visual field examination
Visual light box
Ophthalmology
Class ANon-sterile, non-measuringA light viewing box that uses a translucent version of the ophthalmic chart (Snellen chart) used for testing visual acuity.
Visual projector
Ophthalmology
Class ANon-sterile, non-measuringAn ophthalmic device intended to project an image on a screen to test visual acuity .
Vitrectomy lenses
Ophthalmology
Class ANon-sterile, non-measuringIntended to facilitate the visualization of the retina during Vitrectomy surgery.
Vitrectomy system
Ophthalmology
Class CAn assembly of ophthalmic devices intended to deliver energy through a dedicated hand-held instrument, typically used to treat diabetic vitreous haemorrhage, retinal detachment, epiretinal membrane, and macular hole.
Vitreous body prosthesis
Ophthalmology
Class CA sterile bag/capsule intended to be implanted in the eye and filled with a fluid (not included) to replace the vitreous body and provide omnidirectional support of the retina for the treatment of severe retinal detachment.
Data from CDSCO's online system for medical devices, retrieved 2026-10-31.
Sources
- Risk Classification Approved Device Details, CDSCO online system for medical devices. Retrieved 31 October 2026.
- Merged existing medical devices risk classification, CDSCO public notice, 1 January 2025.
See the full source list and how the data is compiled on the main classification page. This is a reference aid, not legal or regulatory advice.
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