CDSCO risk classification
Dermatological and Plastic Surgery medical device classification
Every dermatological and plastic surgery device in CDSCO's classification register, with its risk class under the Medical Devices Rules, 2017 and its intended use. 19 are Class A non-sterile, non-measuring devices, which are exempt from licensing but must be registered.
- Devices
- 82
- Class A
- 32
- Class B
- 30
- Class C
- 16
- Class D
- 4
Dermatological and Plastic Surgery devices and their class
82 devices
Absorbent Wound Dressing, antimicrobial
Dermatological and Plastic Surgery
Class DA multilayer wound covering having a material or substance (e.g., silicone) on its skin-contact surface and an antimicrobial agent (e.g., silver, etc.), intended to absorb exudate from moderate to heavy exudating wounds, management of moist wound environment, and infection control. It may aid in prevention of adherence to the wound bed thereby decreasing wound trauma potential. This may also be used with minor cuts, lacerations and partial burns. This is a single-use device.
Absorbent Wound Dressing, non-antimicrobial
Dermatological and Plastic Surgery
Class CA multilayer wound covering having a material or substance (e.g., silicone gel) on its skin-contact surface, intended to absorb exudate from heavily exudating wounds and management of moist wound environment. It may aid in prevention of adherence to the wound bed thereby decreasing wound trauma potential; it does not contain an antimicrobial agent. It may be used as a dressing for chronic and postoperative wounds, burns, ulcers, donor sites, trauma wounds, etc. This is a single-use device.
Allergy testing adhesive strip, epicutaneous
Dermatological and Plastic Surgery
Class ANon-sterile, non-measuringA band of adhesive material intended to be used for epicutaneous allergy testing.
Autologous Adipose Tissue Reinjection Cannula, single-use
Dermatological and Plastic Surgery
Class BA sterile, non-powered, hand-held surgical instrument intended for use in conjunction with a fat injection syringe [not included], for transfer and reinjection of processed adipose (fat) tissue into the patient from which the tissue was taken (autologous) as part of regenerative, reconstructive, aesthetic medical procedures. It is a single-use device.
Battery-powered trephine system
Dermatological and Plastic Surgery
Class BA rotary surgical device consisting of a motor (an engine) and a cylindrical or trephine insertion portion. It usually has an extremely sharp-edged saw blade or a cutting blade with a thin saw blade. The blade is beveled on one side. It is used for removal of the intervertebral disc, other hard tissues, or soft tissues. It may have a speed control device. This is a battery- driven device
Breast implant
Dermatological and Plastic Surgery
Class CBreast implant is used to increase the breast size.
Calf implants
Dermatological and Plastic Surgery
Class CImplant for augmentation of calf.
Carbon dioxide laser
Dermatological and Plastic Surgery
Class CA gas laser that is used in surgical procedures. It utilizes carbon dioxide as the substrate. It is widely used in several clinical fields (e.g., gynecology, neuroscience, dermatology).
Colonoscope, General & Plastic Surgery
Dermatological and Plastic Surgery
Class BColonoscopes are used for the removal of foreign bodies, excision of tumors or colorectal polyps (polypectomy), and control of hemorrhage. Routine colonoscopy is important in diagnosing intestinal cancer
Copper vapour laser
Dermatological and Plastic Surgery
Class CA gas laser used in surgical procedures, etc. It utilizes copper vapor as the substrate. It is used in dermatology, etc. for treatment of cutaneous vascular lesions (e.g., port-wine stains, telangiectasia).
Crosslinked sodium hyaluronate
Dermatological and Plastic Surgery
Class CIt is indicated as viscoelastic supplement or a replacement for synovial fluid in human joints. It is suited for treatment of symptoms of human joint dysfunctions such as osteoarthritis. The actions of the product are lubrication and mechanical support.
Cryosurgical unit and accessories
Dermatological and Plastic Surgery
Class BA cryosurgical unit with a liquid nitrogen cooled cryoprobe and accessories is a device intended to destroy tissue during surgical procedures by applying extreme cold.
Dermal dilator
Dermatological and Plastic Surgery
Class BA device to be temporarily implanted subcutaneously to dilate the surrounding skin. Usually, a balloon is implanted subcutaneously where solutions including saline solution are infused.
Dermatome
Dermatological and Plastic Surgery
Class AA surgical knife used to harvest the skin for grafting. Either manual or electric-powered.
Dermatome skin approximation tape
Dermatological and Plastic Surgery
Class ANon-sterile, non-measuringA tape that comes in various sizes with adhesive on both sides. It is attached onto a skin graft knife to collect a skin graft tissue. This device is for single- use.
Dermatome, manual, reusable
Dermatological and Plastic Surgery
Class ANon-sterile, non-measuringA hand-held, manual surgical instrument used for cutting thin donor slices of skin for skin grafting or for excising small skin lesions. This is a reusable device.
Dermatoscope, digital
Dermatological and Plastic Surgery
Class ANon-sterile, non-measuringIntended for non-invasive, visual inspection of intact skin by a healthcare professional. It does not have measuring function.
Digital examination camera
Dermatological and Plastic Surgery
Class ANon-sterile, non-measuringDigital camera for close-up skin inspections or general examinations.
Drape adhesive
Dermatological and Plastic Surgery
Class ANon-sterile, non-measuringA drape adhesive is a device intended to be placed on the skin to attach a surgical drape.
Dressing retention garments
Dermatological and Plastic Surgery
Class ANon-sterile, non-measuringIntended for use in wet and/or dry wrapping and dressing retention in the treatment of atopic eczema. This does not incorporate anti-microbial agents.
Electrically- powered trephine system
Dermatological and Plastic Surgery
Class BA rotary surgical device consisting of a motor (an engine) and a cylindrical or trephine insertion portion. The blade is beveled on one side. It is used for removal of the intervertebral disc, other hard soft tissues, or soft tissues.
Electrosurgical cutting and coagulation device and
Dermatological and Plastic Surgery
Class CElectrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.
Electrosurgical device for over- the- counter aesthetic use
Dermatological and Plastic Surgery
Class BAn electrosurgical device for over-the-counter aesthetic use is a device using radiofrequency energy to produce localized heating within tissues for non- invasive aesthetic use.
Esophagoscope, General & Plastic Surgery
Dermatological and Plastic Surgery
Class BAn endoscope used for visual examination, diagnosis, and treatment of the esophagus. The insertion section changes its shape corresponding to the shape of the body cavity. The device is inserted through the oral cavity.
Extractor, reusable
Dermatological and Plastic Surgery
Class ANon-sterile, non-measuringIt is a hand-held instrument intended to aid in the removal of foreign objects from superficial skin tissue. This is a reusable device.
Eye pad.
Dermatological and Plastic Surgery
Class AAn eye pad is a device that consists of a pad made of various materials, such as gauze and cotton, intended for use as a bandage over the eye for protection or absorption of secretions.
Gas-powered dermatome
Dermatological and Plastic Surgery
Class BA gas pressure-operated surgical device used to cut a thin piece of skin for grafting, or to resect a small skin lesion. A dedicated blade is required for this purpose.
Gas-powered surgical saw
Dermatological and Plastic Surgery
Class BA saw has a handpiece with an attachment that generates vibration or reciprocal movements. It adopts either a micro or macro design. Rechargeable batteries are used. Usually, compressed air or compressed nitrogen is used.
Gas-powered trephine system
Dermatological and Plastic Surgery
Class BA rotary surgical device consisting of a motor (an engine) and a cylindrical or trephine insertion portion. It usually has an extremely sharp-edged saw blade or a cutting blade with a thin saw blade. The blade is beveled on one side. It is used for removal of the intervertebral disc, other hard tissues, or soft tissues. It may have a speed control device. This is a gas- driven device.
Gastroscope, General & Plastic Surgery
Dermatological and Plastic Surgery
Class BA gastroscope is a flexible tube that has a small light and a video camera attached to the end of it. The tube can be used to take tissue samples by inserting instruments such as small pincers.
General electrosurgical unit
Dermatological and Plastic Surgery
Class CA device accompanied by accessories that cuts/coagulates tissues with a high-frequency current or with the electricity/heat of the heating element. The device is used by a physician to confirm that an incision or coagulation is made as intended, macroscopically or microscopically.
Gluteus implants
Dermatological and Plastic Surgery
Class CImplant for augmentation of buttocks.
Haemostatic Dressing Gauze, non-absorbable, biopolymer-based, antimicrobial
Dermatological and Plastic Surgery
Class DA non-absorbable dressing, containing hydrophilic biopolymer (such as chitosan or alginate, etc.), intended to control or stop mild, moderate and severe bleeding for the management of surgical sites, abrasions, lacerations, contusions, puncture wounds, traumatic injuries, and dental applications such as post-extraction bleeding, etc. It acts by producing a water-absorbent gel upon contact with wound exudate and contains an antimicrobial agent (e.g., silver, etc.). This is a single-use device
Hemostatic knife
Dermatological and Plastic Surgery
Class BA surgical severing instrument that is similar to a scalpel, excluding the fact that its blade is designed to be heated with an electric current. The blade transmits heat directly to body tissues to achieve hemostasis. The instrument uses thermal energy for the purpose and requires no grounding pad.
Hook, surgical, skin, reusable
Dermatological and Plastic Surgery
Class ANon-sterile, non-measuringA hand-held, manual surgical instrument intended to fix or apply traction to the skin. This is a reusable device.
Hyaluronic acid (cross linked) Pre-filled syringe
Dermatological and Plastic Surgery
Class CFor intradermal implantation and facial soft tissue augmentation.
Hyaluronic acid with Lidocaine (cross linked) Pre-filled syringe
Dermatological and Plastic Surgery
Class CIt is indicated for the treatment of fine lines and medium sized skin depressions and correcting infraorbital skin depressions via deep injection.
Hydrophilic wound dressing
Dermatological and Plastic Surgery
Class AA hydrophilic wound dressing is a sterile or non- sterile device intended to cover a wound and to absorb exudate. It consists of nonresorbable materials with hydrophilic properties that are capable of absorbing exudate (e.g., cotton, cotton derivatives, alginates, dextran, and rayon).
Hydrophilic wound dressing, non-sterile
Dermatological and Plastic Surgery
Class ANon-sterile, non-measuringA non-sterile device intended to cover a superficial wound and to absorb exudate.
Implantable ligating clip
Dermatological and Plastic Surgery
Class CAn implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.
Implantable staple
Dermatological and Plastic Surgery
Class CAn implantable staple is a staple-like device intended to connect internal tissues to aid healing.
Internal tissue marker
Dermatological and Plastic Surgery
Class AAn internal tissue marker is a prescription use device that is intended for use prior to or during general surgical procedures to demarcate selected sites on internal tissues.
Irrigating wound retractor device
Dermatological and Plastic Surgery
Class BAn irrigating wound retractor device is a prescription device intended to be used by a surgeon to retract the surgical incision, to provide access to the surgical wound, to protect and irrigate the surgical wound, and to serve as a conduit for removal of fluid from the surgical wound
Laparoscope, General & Plastic Surgery
Dermatological and Plastic Surgery
Class B"These electrodes are intended for use in minimally invasive surgical procedures where monopolar electrosurgical cutting and coagulation are desired
Laparoscopy Tray
Dermatological and Plastic Surgery
Class ALaparoscopy Tray is intended for single-use to enable a suitable trained health care professional to perform an laparoscopic procedure.
Laser Lipolysis System Handpiece/Cannula set
Dermatological and Plastic Surgery
Class CA component of a laser lipolysis system, consisting of a handpiece and a (replaceable) cannula/needle, intended for use in conjunction with a medical diode laser system [not included] for the application of (laser) thermal energy for small-or large-volume fat extraction, body contouring and subcutaneous fat harvesting from areas such as abdomen, inner and outer thighs, etc.
Laser surgical instrument for use in general and plastic surgery and in dermatology
Dermatological and Plastic Surgery
Class CA carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.
Liposuction catheter
Dermatological and Plastic Surgery
Class BA rigid tube inserted into the subcutaneous layer transdermally for removal of fatty deposits. Aspiration is performed with an appropriate unit. This device is for single-use.
Low energy ultrasound wound cleaner
Dermatological and Plastic Surgery
Class BA low energy ultrasound wound cleaner is a device that uses ultrasound energy to vaporize a solution and generate a mist that is used for the cleaning and maintenance debridement of wounds.
Manual operating table and accessories and manual operating chair and accessories
Dermatological and Plastic Surgery
Class AA manual operating table and accessories and a manual operating chair and accessories are non- powered devices, usually with movable components, intended to be used to support a patient during diagnostic examinations or surgical procedures.
Manually-operated dermatome
Dermatological and Plastic Surgery
Class AA hand-held surgical device used to sever a thin piece of skin for grafting, or to resect a small skin lesion. A dedicated blade is required for this purpose.
Non-powdered surgeon's glove
Dermatological and Plastic Surgery
Class AA non-powdered surgeon's glove is a device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination
Occlusive wound dressing
Dermatological and Plastic Surgery
Class AAn occlusive wound dressing is a nonresorbable, sterile or non-sterile device intended to cover a wound, to provide or support a moist wound environment, and to allow the exchange of gases such as oxygen and water vapor through the device.
Organ bag
Dermatological and Plastic Surgery
Class BAn organ bag is a device that is a flexible plastic bag intended to be used as a temporary receptacle for an organ during surgical procedures to prevent moisture loss.
Plastic surgery osteotome
Dermatological and Plastic Surgery
Class AA surgical, chisel-like, instrument designed to cut and/or shape small bones and/or cartilage during plastic surgery. It is hand-held by the surgeon who will typically use a surgical mallet or hammer to manually impart an impacting force to the proximal end of the instrument.
Plastic surgery osteotome, reusable
Dermatological and Plastic Surgery
Class ANon-sterile, non-measuringA hand-held, manual surgical instrument intended to cut and/or shape small bones and/or cartilage during plastic surgery. This is a non-measuring, reusable device intended to be sterilized prior to use.
Powered corneal trephine
Dermatological and Plastic Surgery
Class BAn electric cylindrical device for ophthalmic surgery equipped with a blade for resection/removal of a ring- shaped piece of corneal tissue (corneal button). For example, when a healthy corneal graft is obtained from a cadaver, the recipient's morbid cornea is resected and removed to allow transplantation of the graft.
Powered dermatome
Dermatological and Plastic Surgery
Class BAn electric surgical device used for removal of the fragment of damaged skin or for thinly slicing the skin of a donor for skin graft. A dedicated blade should be used for these purposes.
Powered suction pump.
Dermatological and Plastic Surgery
Class BA powered suction pump is a portable, AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patients airway or respiratory support system. The device may be used during surgery in the operating room or at the patients bedside. The device may include a microbial filter
Removable skin clip
Dermatological and Plastic Surgery
Class BA removable skin clip is a clip-like device intended to connect skin tissues temporarily to aid healing. It is not absorbable
Removable skin staple
Dermatological and Plastic Surgery
Class BA removable skin staple is a staple-like device intended to connect external tissues temporarily to aid healing. It is not absorbable.
Retractor, plastic surgery, reusable
Dermatological and Plastic Surgery
Class ANon-sterile, non-measuringA reusable manual surgical instrument intended for use in plastic surgery for separating tissue or other anatomical parts to expose or access organs or tissues. This is a reusable device intended for transient use only.
Reusable dermatome blade
Dermatological and Plastic Surgery
Class ANon-sterile, non-measuringA blade that comes in various sizes, attached to the skin graft knife, and is used to harvest the skin graft. This device is reusable after sterilization. Usually, the blade point should be sharpened periodically.
Scar-management dressing
Dermatological and Plastic Surgery
Class ANon-sterile, non-measuringA covering made of, or coated with, a synthetic polymer material (e.g., silicone gel) intended to be applied directly to the intact skin for the management of hypertrophic or keloid scars by hydrating and reducing red, dark, or raised scars resulting from surgery, accidents, cuts, burns, or other injuries. This is not intended for open wounds or surgical incisions. This is supplied as non-sterile.
Scissors, plastic surgery, reusable
Dermatological and Plastic Surgery
Class ANon-sterile, non-measuringA hand-held, manual instrument intended to cut tissue during plastic surgery. This is a reusable device intended for transient use.
Single-use dermatome blade
Dermatological and Plastic Surgery
Class BA blade, available in various sizes, attached to a dermatome for collection of skin grafts. The device is intended for single-use.
Skin graft mesher, reusable
Dermatological and Plastic Surgery
Class ANon-sterile, non-measuringA manually operated device intended to perforate and stretch the donor skin graft with a pattern of lacerations before the skin is grafted to the patient. This is a reusable device.
Skin marker
Dermatological and Plastic Surgery
Class AA skin marker is a pen-like device intended to be used to write on the patients skin, e.g., to outline surgical incision sites or mark anatomical sites for accurate blood pressure measurement.
Skin Stapler
Dermatological and Plastic Surgery
Class BSkin Stapler is intended to be applied to close lacerations on the outer layer of the dermis.
Soft tissue trephine
Dermatological and Plastic Surgery
Class BA cylindrical or coronary saw used to resect discs of tissues other than bones. It comes in various sizes and configurations according to the size and hardness of the tissue to be resected.
Surgical apparel
Dermatological and Plastic Surgery
Class ASurgical apparel are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate
Surgical camera and accessories
Dermatological and Plastic Surgery
Class ANon-sterile, non-measuringA surgical camera and accessories is a device intended to be used to record operative procedures.
Surgical drape and drape accessories
Dermatological and Plastic Surgery
Class BA surgical drape and drape accessories is a device made of natural or synthetic materials intended to be used as a protective patient covering to isolate a site of surgical incision from microbial and other contamination.
Surgical guillotine
Dermatological and Plastic Surgery
Class AA cutter that consists of a metal frame. The cutter slides through the frame. It comes in various configurations and sizes according to the type of tissue to be severed. Various cranks or shaft driver mechanisms generate the power.
Surgical lamp
Dermatological and Plastic Surgery
Class ANon-sterile, non-measuringIdentification. A surgical lamp (including a fixture) is a device intended to be used to provide visible illumination of the surgical field or the patient.
Surgical microscope and accessories
Dermatological and Plastic Surgery
Class ANon-sterile, non-measuringA surgical microscope and accessories is an AC- powered device intended for use during surgery to provide a magnified view of the surgical field.
Suture retention device
Dermatological and Plastic Surgery
Class BA suture retention device is a device, such as a retention bridge, a surgical button, or a suture bolster, intended to aid wound healing by distributing suture tension over a larger area in the patient
Ultraviolet lamp for dermatologic disorders.
Dermatological and Plastic Surgery
Class BAn ultraviolet lamp for dermatologic disorders is a device (including a fixture) intended to provide ultraviolet radiation of the body to photo activate a drug in the treatment of a dermatologic disorder if the labeling of the drug intended for use with the device bears adequate directions for the device's use with that drug.
Wound auto fluorescence imaging device
Dermatological and Plastic Surgery
Class BA wound auto fluorescence imaging device is a tool to view auto fluorescence images from skin wounds that are exposed to an excitation light. The device is not intended to provide quantitative or diagnostic information.
Wound Hydrogel Dressing, antimicrobial
Dermatological and Plastic Surgery
Class DA wound covering, typically made of cross-linked polymer gels (e.g., hyaluronic acid, etc.) and incorporated antimicrobials (e.g., silver, etc.), intended to promote healing and management of deep wounds including post-operative incisions, pressure sores, dermal ulcers, diabetic ulcers, venous stasis ulcers, first and second degree burns, etc., by maintaining a moist wound environment; it may also facilitate wound debridement and/or absorb exudates in wounds that are minimally to moderately exudative. This is a single-use device.
Wound Hydrogel Dressing, non-antimicrobial
Dermatological and Plastic Surgery
Class CA wound covering typically made of cross-linked polymer gels (e.g., hyaluronic acid) intended to promote healing and management of deep wounds including post-operative incisions, pressure sores, dermal ulcers, diabetic ulcers,venous stasis ulcers, first and second degree burns, etc., by maintaining a moist wound environment; it may also facilitate wound debridement and/or absorb exudates in wounds that are minimally to moderately exudative. This is a single-use device.
Wound matrix dressing, animal/human-derived
Dermatological and Plastic Surgery
Class DA sterile, bioabsorbable, animal/human-derived wound covering (cells/tissues rendered completely non-viable) intended to provide a matrix of structural proteins and a template for wound/skin healing. It may be available in various forms [e.g., solution, powder, occlusive/semi-occlusive cover (non-oral)] and may include additional compounds (e.g., alginate, etc.)]. It is commonly intended for treating partial- and full-thickness wounds, ulcers, and draining, surgical, and traumatic wounds. It is NOT a biological allograft. It is a single-use 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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