CYNOSURE ACCOLADE LASER

K992814 · Cynosure, Inc. · GEX · Sep 15, 1999 · General, Plastic Surgery

Device Facts

• Record ID: K992814
• Device Name: CYNOSURE ACCOLADE LASER
• Applicant: Cynosure, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Sep 15, 1999
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Tattoo and benign cutaneous pigmented lesions removal.

Device Story

Cynosure Accolade Laser is a medical laser system designed for removal of tattoos and benign cutaneous pigmented lesions. Device comprises three interconnected sections: power supply, water cooling system, and optical bench. Operated by healthcare professionals in clinical settings. System delivers laser energy to target tissue; biological effects are consistent with established laser-tissue interactions for dermatological applications. Output allows clinicians to perform targeted removal of pigmented lesions and tattoos, providing a therapeutic benefit for patients seeking cosmetic or medical skin treatment.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Medical laser system consisting of power supply, water cooling system, and optical bench. Class II device (21 CFR 878.48).

Indications for Use

Indicated for the removal of tattoos and benign cutaneous pigmented lesions in patients requiring laser therapy.

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

• Cynousre PhotoGenica HT10 Laser

Submission Summary (Full Text)

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

SEP 1 5 1500

## 长992814

## 510(K) Summary

| Submitter: | Cynosure, Inc.<br>10 Elizabeth drive<br>Chelmsford, MA 01824 |
|-------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | George Cho<br>Senior Vice President of Medical Technology |
| Date Summary Prepared: | August 18, 1999 |
| Device Trade name: | Cynosure Accolade Laser |
| Common Name: | Medical Laser System |
| Classification Name: | Instrument, surgical, powered, laser<br>79-GEX<br>21 CFR 878.48 |
| Equivalent Device | Cynosure PhotoGenica HT10 Laser |
| Device description: | The Accolade Laser consists of three<br>interconnected sections: the power supply, the<br>water cooling system and the optical bench. |
| Intended Use: | Tattoo and benign cutaneous pigmented lesions<br>removal. |
| Comparison: | The Accolade Laser is substantially equivalent to<br>the Cynosure PhotoGenica HT10 Laser in terms<br>of treatment wavelength, pulse duration, pulse<br>energy, and biological effects. |
| Nonclinical Performance Data: | None |
| Clinical Performance Data: | None |
| Conclusion: | The Cynosure Accolade Laser is another safe and<br>effective laser for tattoo and benign cutaneous<br>pigmented lesions removal. |
| Additional Information: | None requested at this time. |

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

Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 5 1999

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

Re: K992814 Trade Name: Cynosure Accolade Laser Regulatory Class: II Product Code: GEX Dated: August 18, 1999 Received: August 20, 1999

Dear Mr. Cho:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition. FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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

Page 2 - Mr. George Cho

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D.

Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

Page_ of

510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

Device Name: Cynosure Accolade Laser

Indications For Use:

The Cynosure Accolade Laser is indicated for tattoo and benign cutaneous pigmented lesions removal.

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

## Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

OR

Over-The-Counter Use_

(Optional Format 1-2-96)

A. Coley

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K992814