CYNOSURE DIODERM

K992765 · Cynosure, Inc. · GEX · Sep 8, 1999 · General, Plastic Surgery

Device Facts

• Record ID: K992765
• Device Name: CYNOSURE DIODERM
• Applicant: Cynosure, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Sep 8, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The DioDerm Laser is intended for use in dermatology for photocoagulation of vascular lesions.

Device Story

Cynosure DioDerm Laser is a medical laser system used in dermatology. It functions by delivering laser energy to target and photocoagulate vascular lesions. The device is operated by a physician or trained clinician in a clinical setting. By inducing photocoagulation, the laser treats vascular abnormalities, providing a therapeutic benefit to the patient. The device is intended for professional use only.

Clinical Evidence

No clinical data provided; substantial equivalence determination based on 510(k) notification and regulatory review.

Technological Characteristics

Laser system designed for dermatological photocoagulation. Operates as a medical laser device (Product Code: GEX). Technical specifications and materials are consistent with standard dermatological laser systems regulated under 21 CFR Part 800-895.

Indications for Use

Indicated for use in dermatology for the photocoagulation of vascular lesions in patients requiring such treatment.

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.

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with three lines above them.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

18 1999 SEP

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

Re: K992765 Trade Name: Cynosure DioDerm Laser Regulatory Class: II Product Code: GEX Dated: August 16, 1999 Received: August 17, 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 (OS) 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.

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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

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510(k) Number (if known): K95276

Device Name: Cynosure DioDerm Laser

Indications For Use:

The DioDerm Laser is intended for use in dermatology for photocoagulation of vascular lesions.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Poole

(Division Sign-Off)
Division of General Restorative Devices K992765
510(k) Number

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________