VIRIDIS TWIN OPHTHALMIC PHOTOCOAGULATOR

K023464 · Quantel Medical · GEX · Jan 13, 2003 · General, Plastic Surgery

Device Facts

• Record ID: K023464
• Device Name: VIRIDIS TWIN OPHTHALMIC PHOTOCOAGULATOR
• Applicant: Quantel Medical
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Jan 13, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Viridis Twin laser is indicated for the photocoagulation or ablation of pigmented tissue within the eye. The 532 nm wavelength is indicated for use for: retinal photocoagulation proliferative diabetic retinopathy, macular degeneration, and retinal detachment. peripheral photocoagulation proliferative diabetic retinopathy, macular degeneration, and retinal detachment. endophotocoagulation (EPCP) intraocular photocoagulation as an adjunct in vitrectomy surgery, complicated rhegmatogeous, tractional retinal detachments, proliferative vitreoretinopathy, proliferative diabetic retinopathy, retinopathy, and retinal vascular tumors. The 810 nm wavelength is indicated for use for: photocoagulation or ablation of pigmented tissue within the eye, transscleral ciliary body ablation (treatment is reserved for patients with chronic glaucoma and those not responding to conventional treatments), limited and pan-retinal photocoagulation, transpupillary photocoagulation, endophotocoagulation, treatment of complicated rhegmatogeous, tractional retinal detachments, proliferative vitreoretinopathy, proliferative diabetic retinopathy, macular degeneration, peripheral photocoagulation (recumbent patients), transpupillary photocoagulation of choriodal neovasculature, and age-related macular degeneration (AMD) treatments.

Device Story

Viridis Twin Ophthalmic Photocoagulator is a dual-wavelength laser system combining a 532 nm frequency-doubled Nd:YAG laser and an 810 nm diode laser. Device delivers coherent light energy to ocular tissues to perform photocoagulation or ablation. User selects desired wavelength and attaches compatible delivery systems—such as slit lamp adapters, biomicroscopes, endoprobes, or indirect ophthalmoscopes—to the laser aperture. Operated by ophthalmologists in clinical settings. Output energy is directed to treatment sites to manage conditions like diabetic retinopathy, macular degeneration, and glaucoma. Device provides therapeutic benefit by enabling precise tissue coagulation or ablation, aiding in the management of retinal and choroidal pathologies.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Dual-wavelength ophthalmic laser system: 532 nm frequency-doubled Nd:YAG and 810 nm diode laser. Class II device (21 CFR 886.4390). Compatible with standard ophthalmic delivery systems including slit lamp adapters, biomicroscopes, endoprobes, and indirect ophthalmoscopes. Standalone system.

Indications for Use

Indicated for patients requiring photocoagulation or ablation of pigmented ocular tissue, including those with proliferative diabetic retinopathy, macular degeneration, retinal detachment, proliferative vitreoretinopathy, retinal vascular tumors, and chronic glaucoma unresponsive to conventional treatments.

Regulatory Classification

Identification

(1) A 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.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.

Predicate Devices

• Viridis Laser (K960867)
• Novus Verdi Delivery Systems (K991258)

Reference Devices

• IRIS Medical OcuLight SL/SLx (K020374)
• Nidek DC-3300 (K013760)

Submission Summary (Full Text)

{0}------------------------------------------------

## SECTION 10

## 510(k) SUMMARY

K023464

This 510(k) summary of safety and effectiveness for the modification in the Indications for Use for the Viridis Twin laser is submitted in accordance with the requirements of SMDA 1990 and follows Office of Device Evaluation guidance concerning the organization and content of a 510(k) summary.

Quantel Medical Applicant: QUANTEL MEDICAL Address: 21 rue Newton Z.I. du Br zet 63039 Clermont-Ferrand Cedex 2 FRANCE [phone] [phone] (Fax) Contact Person: Mr. Jean Abascal Regulatory Affairs Manager ([phone] : ([phone] Preparation Date: September 2002 (of the Summary) Viridis Twin Ophthalmic Photocoagulator Device Name: Ophthalmic Laser, frequency doubled Nd: Y AG (532 nm) laser Common Name: Laser Surgical Instrument, frequency doubled Nd: Y AG (532 nm) laser Ophthalmic Laser, 810 nm diode laser Laser Surgical Instrument; 810 nm diode laser Classification Ophthalmic laser (see 21 CFR 886.4390) Name: Laser surgical instrument (see: 21 CFR 878.4810). Product Code: HQF; Panel: 86 Product Code: GEX; Panel: 79 Predicate devices: Viridis Laser (K960867); Novus Verdi Delivery Systems (K991258) -and the Viridis laser

{1}------------------------------------------------

IRIS Medical OcuLight SL/SLx (K020374); Nidek DC-3300 (K013760) The predicate lasers utilize several delivery systems, including slit lamp adapters, biomicroscopes, endoprobes, and indirect ophthalmoscopes to deliver the laser energy to the treatment sites.

The delivery systems used with the Viridis Twin Ophthalmic Photocoagulator are the same as or similar to delivery systems supplied with or used with other ophthalmic photocoagulators operating at 532 nm and/or 810 nm. These devices are independently marketed by their respective manufacturers which are responsible for complying with regulatory and marketing requirements. The cited models are compatible for use with the Viridis Twin Ophthalmic Photocoagulator.

- Device description: The Viridis Twin Ophthalmic Photocoagulator is a combination system consisting of a Nd:YAG frequency doubled laser which emits a beam of coherent light at 532 nm and a diode laser which emits a beam of coherent light 810 microns. The treatment beam is selected by the user, the delivery system is attached to the appropriate laser aperture, and the energy is delivered to the treatment site(s) via delivery systems/devices.
- Quantel Viridis Twin Ophthalmic Photocoagulator is indicated Indications: The for the photocoagulation or ablation of pigmented tissue within the eye.

The 532 nm wavelength is indicated for use for:

retinal photocoagulation proliferative diabetic retinopathy, macular degeneration, and retinal detachment. peripheral photocoagulation proliferative diabetic retinopathy, macular degeneration, and retinal detachment. endophotocoagulation (EPCP) intraocular photocoagulation as an adjunct in vitrectomy surgery, complicated rhegmatogeous, tractional retinal detachments, proliferative vitreoretinopathy, proliferative diabetic retinopathy, retinopathy, and retinal vascular tumors.

The 810 nm wavelength is indicated for use for:

photocoagulation or ablation of pigmented tissue within the eye, transscleral ciliary body ablation (treatment is reserved for patients with chronic glaucoma and those not responding to conventional treatments), limited and pan-retinal photocoagulation, transpupillary photocoagulation,

{2}------------------------------------------------

endophotocoagulation,

treatment of complicated rhegmatogeous, tractional retinal detachments, proliferative vitreoretinopathy, proliferative diabetic retinopathy, macular degeneration, peripheral photocoagulation (recumbent patients),

transpupillary photocoagulation of choriodal neovasculature, and

age-related macular degeneration (AMD) treatments.

Performance Data: None required.

- CONCLUSION: Based on the information in this notification Quantel Medical concludes that the Viridis Twin Ophthalmic Photocoagulator is substantially equivalent to the cited legally marketed predicates. Information regarding delivery systems which may be used with the laser is supplied by Quantel Medical; the individual devices or systems are marketed by their respective manufacturers who have the responsibility for complying with applicable regulations and marketing requirements.
Revised: January 2003

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three stripes forming its body and wing. The eagle faces left and is enclosed within a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the border of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 3 2003

Quantel Medical c/o Roger W. Barnes 342 Sunset Bay Road Hot Springs, Arkansas 71913

Re: K023464

Trade/Device Name: Viridis Twin Ophthalmic Photocoagulator Regulation Number: 886.4390 Regulation Name: Laser surgical instrument Regulatory Class: Class II Product Code: GEX Dated: October 9, 2002 Received: October 15, 2002

Dear Mr. Barnes:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in

{4}------------------------------------------------

Page 2 – Mr. Roger W. Barnes

the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510/k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97): Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.qov/cdrh/dsma/dsmamain.html

Sincerely yours,

Mark N. Milkinson

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

## SECTION 7

## INDICATIONS FOR USE STATEMENT

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Viridis Twin laser

Indications for Use Statement:

The Viridis Twin laser is indicated for the photocoagulation or ablation of pigmented tissue within the eye.

The 532 nm wavelength is indicated for use for:

retinal photocoagulation proliferative diabetic retinopathy, macular degeneration, and retinal detachment. peripheral photocoagulation proliferative diabetic retinopathy, macular degeneration, and retinal detachment. endophotocoagulation (EPCP) intraocular photocoagulation as an adjunct in vitrectomy surgery, complicated rhegmatogeous, tractional retinal detachments, proliferative vitreoretinopathy, proliferative diabetic retinopathy, retinopathy, and retinal vascular tumors.

The 810 nm wavelength is indicated for use for:

photocoagulation or ablation of pigmented tissue within the eye, transscleral ciliary body ablation (treatment is reserved for patients with chronic glaucoma and those not responding to conventional treatments),

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

| Concurrence of CDRH, Office of Device Evaluation | |
|--------------------------------------------------|----|
| Prescription Use | OR |
| (Per 21 CFR 801.109) | |

Over-The Counter Use

{6}------------------------------------------------

limited and pan-retinal photocoagulation, transpupillary photocoagulation,

endophotocoagulation,

treatment of complicated rhegmatogeous, tractional retinal detachments, proliferative vitreoretinopathy, proliferative diabetic retinopathy, macular degeneration, peripheral photocoagulation (recumbent patients), transpupillary photocoagulation of choriodal neovasculature, and

age-related macular degeneration (AMD) treatments.

revised: January 2003