CDSCO risk classification
Ophthalmic medical device classification
Every ophthalmic device in CDSCO's classification register, with its risk class under the Medical Devices Rules, 2017 and its intended use. 8 are Class A non-sterile, non-measuring devices, which are exempt from licensing but must be registered.
- Devices
- 25
- Class A
- 10
- Class B
- 15
- Class C
- 0
- Class D
- 0
Ophthalmic devices and their class
25 devices
AI-based Vision Testing Software, professional-use
Ophthalmic
Class AA standalone web-based or mobile device software application intended for use by healthcare personnel (ophthalmologists, optometrists, etc.) for screening of vision-related parameters, such as visual acuity, near/far vision, colour perception, depth perception, contrast sensitivity, spherical refractive error, astigmatism, etc. It may operate in conjunction with a smartphone and/or a virtual reality (VR) headset. It provides a summarized report to the healthcare personnel of all results and may include AI recommendations. It is not intended for definitive diagnosis or evaulation or to replace clinical judgement. This is NOT intended for use as an aid in screening of serious ocular pathologies or as a self-assessment tool.
Aspiration Line Pressure Sensor
Ophthalmic
Class BA sterile device, consisting of a pressure dome, membrane, tubing, etc., intended for use in connection with the peristaltic pump [not included] of a phacoemulsification system [not included] to measure and monitor the pressure in the aspiration/irrigation tubing during ophthalmic interventions. This is a single-use device.
Corneal Staining Strip/Ophthalmic Strips
Ophthalmic
Class BAn ophthalmic strip, impregnated with dyes (e.g., fluorescein sodium, lissamine green, etc.) intended to stain the cornea for purposes such as fitting contact lenses, to disclose corneal injury (e.g., to enhance superficial abrasions for examination), in applanation tonometry, or evaluation of dry eye condition, etc. This is a single-use device.
Eye Dropper Bottle Aid
Ophthalmic
Class ANon-sterile, non-measuringA non-sterile device intended to be attached to an eye dropper bottle [not included] to assist with the self-administration of an eye irrigation/treatment solution. This is a reusable device.
Eye Lubricant - Sterile Hydroxy Propyl Methyl Cellulose
Ophthalmic
Class BA substance containing sterile Hydroxy Propyl Methyl Cellulose (HPMC) intended to supplement lubrication/hydration in eyes to relieve dry eye conditions. It may also be used to moisten hard contact lenses and to lubricate artificial eyes.
Lens Loop, reusable
Ophthalmic
Class BA non-powered, handheld ophthalmic surgical instrument intended to be introduced into the anterior chamber of the eye to manipulate, engage, or extract the crystalline lens or lens fragments during ophthalmic surgery. This is a reusable device.
Manual Intraocular Lens Injector, reusable
Ophthalmic
Class BA hand-held, manual, ophthalmic surgical instrument intended to inject a prepared (folded) intraocular lens (IOL) from an insertion cartridge (not included) in the eye during ophthalmic surgery. This is a reusable device and does not include IOL.
Ophthalmic Bimanual Handpiece
Ophthalmic
Class BAn ophthalmic surgical tool, intended to be connected to phacoemulsification or surgical machine, to deliver irrigation solution and perform aspiration during eye surgeries like phacoemulsification, etc. It is a reusable device intended to be sterilized prior to use.
Ophthalmic Blade Handle, reusable
Ophthalmic
Class ANon-sterile, non-measuringA non-powered surgical instrument intended to securely hold a disposable ophthalmic surgical blade to facilitate precise incisions during ocular surgery. This is a reusable device intended to be sterilized prior to use.
Ophthalmic Fixation Ring
Ophthalmic
Class BA hand-held, non-powered device intended to immobilize the eye (globe) and provide stabilization during ophthalmic surgeries. This is not intended as a cutting, clamping, levering, or retracting instrument. This may be a reusable/single-use device.
Ophthalmic Intraocular Lens (IOL) Manipulator
Ophthalmic
Class AA sterile, non-powered, hand-held ophthalmic instrument intended for handling, positioning and manipulation of intraocular lens (IOL) during ophthalmic interventions. It is not an IOL injector. This is a reusable device intended to be sterilized prior to use.
Ophthalmic Knife, reusable
Ophthalmic
Class BA hand-held, manual, ophthalmic surgical instrument intended to make precise incisions in the eye and surrounding tissues during ophthalmic surgery. This is a reusable device intended to be sterilized prior to use.
Ophthalmic Lens Expressor, reusable
Ophthalmic
Class ANon-sterile, non-measuringA hand-held, mechanical ophthalmic surgical instrument intended for manual manipulation, expression, or dislocation of the crystalline lens by gently applying pressure to the eye during ophthalmic interventions. It may also be used to manipulate the position of intraocular lens (IOL) within the capsular bag during cataract surgery. This is a transient-use, reusable device intended to be sterilized prior to use.
Ophthalmic Phaco Chopper
Ophthalmic
Class BA reusable, hand-held, rod-like ophthalmic surgical instrument intended to mechanically divide (chop) the cloudy lens nucleus into smaller, manageable pieces during cataract surgery.
Ophthalmic Polisher
Ophthalmic
Class BA hand-held, manual surgical device intended for use in ophthalmic surgery to perform controlled polishing of intraocular structures, including the posterior capsule and corneal surfaces, to remove residual tissue and improve surface smoothness and clarity. This may be a reusable/single-use device.
Ophthalmic Slit Lamp Imaging System
Ophthalmic
Class ANon-sterile, non-measuringA collection of devices intended for capturing images of ocular structures using a slit lamp/ophthalmic microscope and subsequently digitally processing them for storage, documentation and further clinical analysis. It does not have any additional diagnostic capability or functionality for measuring anatomical/physiological parameters.
Ophthalmic Spatula, reusable
Ophthalmic
Class ANon-sterile, non-measuringA non-powered, handheld, manual surgical instrument intended for atraumatic manipulation of ocular tissues during ophthalmic surgical interventions. This is a reusable device intended to be sterilized prior to use.
Ophthalmic Sponge
Ophthalmic
Class BA device intended to be used to absorb excess fluid produced by the eye during microsurgical procedures or ophthalmic surgery. It may also be used to wipe and clean ocular tissues/surgical field. This is a single-use device.
Ophthalmic Surgical Laser Lens
Ophthalmic
Class BA device intended for use in conjunction with an ophthalmic laser system [not included] to modify the convergence of the light rays of an ophthalmic laser beam to coagulate or cut tissues of the eye, the orbit, or the surrounding skin during ophthalmic interventional procedures. It may also be used in diagnostic examinations.
Phacoemulsification system hand piece tip, reusable
Ophthalmic
Class BAn ophthalmic surgical device, intended for use in conjunction with a phacoemulsification handpiece [not included], to deliver ultrasonic/piezoelectric energy to emulsify the lens nucleus. It may also facilitate, via the handpiece, irrigation/suction needed for the removal of debris.
Phacoemulsification System Stand/Trolley
Ophthalmic
Class ANon-sterile, non-measuringA specialized device intended to serve as a stand for phacoemulsification system (not included) and related accessories during ophthalmic interventions. It may be mobile and include an adjustable IV pole.
Retinoscope, battery-powered
Ophthalmic
Class ANon-sterile, non-measuringA battery-powered ophthalmic instrument intended for objective measurement of the refractive errors of the eye through the projection of a beam of light into the eye, and the observation of the movement of the illuminated area on the retinal surface and of the refraction of the emergent rays. This does not have a measuring function. This is a reusable device.
Scleral Fixation Device, single-use
Ophthalmic
Class BA specially-designed, sterile, hand-held, manual ophthalmic instrument intended for docking of Intraocular Lens (IOL) haptics during Scleral Fixation IOL (SFIOL) surgery. This is a single-use device.
Thermal cautery, manual
Ophthalmic
Class BA hand-held, manual ophthalmic surgical instrument intended to be heated externally by a heat source and applied to the target site for coagulating tissue or arresting bleeding from small blood vessels during eye surgery. This is not an electrosurgical device. This is a reusable device.
Veterinary Intraocular medicine delivery device
Ophthalmic
Class ANon-sterile, non-measuringA non-sterile, non-powered, manually-operated device intended for transient intraocular delivery/administration of vaccines/drug in poultry. It is not a prefilled device. This is a reusable device.
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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