CYNOSURE PHOTOGENICA VL

K032565 · Cynosure, Inc. · GEX · Oct 22, 2003 · General, Plastic Surgery

Device Facts

• Record ID: K032565
• Device Name: CYNOSURE PHOTOGENICA VL
• Applicant: Cynosure, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Oct 22, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Cynosure PhotoGenica VL laser is indicated for use in Dermatological and Plastic Surgery applications and the treatment of periocular wrinkles, vascular lesions and inflammatory acne vulgaris.

Device Story

PhotoGenica VL is a pulsed-dye laser system using organic dye as the lasing medium; emits light at 580-590nm wavelength. Device operated by physician in clinical setting; activation via finger switch or footswitch. System provides laser energy for dermatological and plastic surgery applications, specifically targeting vascular lesions, inflammatory acne, and periocular wrinkles. Output allows for precise tissue treatment; clinical benefit includes non-invasive management of specified skin conditions. System is a floor-standing unit (285 lbs) requiring 110/220 VAC power.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Pulsed-dye laser; organic dye lasing medium; 580-590nm wavelength; 110/220 VAC, 20A, 50-60 Hz power; dimensions 44"x19"x24"; finger/footswitch activation.

Indications for Use

Indicated for patients requiring dermatological or plastic surgery procedures, specifically for the treatment of periocular wrinkles, vascular lesions, and inflammatory acne vulgaris.

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

• Nlite Laser by ICN
• Cynosure PhotoGenica VL

Submission Summary (Full Text)

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K032565 1 of 1

## 510(k) SUMMARY

OCT 2 2 2003

| Submitter: | Cynsoure, Inc.<br>10 Elizabeth Drive<br>Chelmsford, MA 01824 |
|-------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | George Cho<br>Senior Vice President of Medical Technology |
| Date Summary Prepared: | August 19, 2003 |
| Device Trade Name: | PhotoGenica VL |
| Common Name: | Medical Laser System |
| Classification Name: | Instrument, surgical, powered, laser<br>79-GEX<br>21 CFR 878.4810 |
| Equivalent Device: | Nlite Laser by ICN, and Cynosure PhotoGenica VL |
| Device Description: | The PhotoGenica VL is a pulse-dye laser, having the<br>organic dye as the lasing medium. It is a pulsed laser<br>with a wavelength of 580 to 590nm. |
| | Laser activation is both by finger switch and footswitch.<br>Overall weight of the laser is 285lbs, and the size is<br>44"x19"x24" (HxWxD). |
| | Electrical requirement is 110 VAC or 220 VAC, 20A,<br>50-60 Hz, single phase. |
| Intended Use: | The PhotoGenica VL is indicated for treatment of<br>periocular wrinkles, vascular lesions and inflammatory<br>acne. |
| Comparison: | The PhotoGenica VL laser has an equivalent indication<br>for uses, the same principle of operation, the same<br>wavelength and pulse energy range as the predicate<br>devices. |
| Nonclinical Performance Data: | none |
| Clinical Performance Data: | none |
| Conclusion: | The PhotoGenica VL Laser is another safe and effective<br>device for dermatologic applications. |
| Additional Information: | none |

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 2 2003

Mr. George Cho Senior Vice President of Medical Technology Cynosure, Inc. 10 Elizabeth Drive Chelmsford. Massachusetts 01824

Re: K032565 Trade/Device Name: PhotoGenica VL Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: August 19, 2003 Received: August 21, 2003

Dear Mr. Cho:

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

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Page 2 - Mr. George Cho

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]. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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.gov/cdrh/dsma/dsmamain.html

Sincerely vours.

Mark N Milkenm

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

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501(k) Number (if known):

K032565

Device Name:

Cynosure PhotoGenica VL

Indications For Use:

The Cynosure PhotoGenica VL laser is indicated for use in Dermatological and Plastic Surgery applications and the treatment of periocular wrinkles, vascular lesions and inflammatory acne vulgaris.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of General, Restorative
and Neurological Devices
510(k) Number

Prescription Use
(Per 21 CFR 801.109)

OR

Over-the-Counter Use
(Optional Format 1-2-96)