CYNOSURE PHOTOLIGHT FLASHLAMP SYSTEM

K974674 · Cynosure, Inc. · GEX · Apr 29, 1998 · General, Plastic Surgery

Device Facts

• Record ID: K974674
• Device Name: CYNOSURE PHOTOLIGHT FLASHLAMP SYSTEM
• Applicant: Cynosure, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Apr 29, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

For the treatment of benign cutaneous vascular lesions

Device Story

The PhotoLight System is a high-intensity flashlamp device designed for the photocoagulation of benign cutaneous vascular lesions. It utilizes optical energy to treat vascular conditions. The device is intended for use by healthcare professionals in a clinical setting. By delivering pulsed light energy to the target tissue, the system facilitates the coagulation of vascular lesions, providing a therapeutic benefit for patients with these conditions.

Clinical Evidence

No clinical performance data provided. No nonclinical performance data provided.

Technological Characteristics

High-intensity flashlamp system utilizing optical energy for photocoagulation. Classified as a powered surgical instrument (21 CFR 878.4810).

Indications for Use

Indicated for the treatment of benign cutaneous vascular lesions in patients requiring photocoagulation 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

• PhotoDerm VL (ESC Medical Systems)

Submission Summary (Full Text)

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APR 2 9 1998

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K974674

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## 510(k) Summary

| Submitter | Cynosure, Inc. 10 Elizabeth Drive Chelmsford, MA 01824 |
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| Contact | George Cho Senior Vice President |
| Date Summary Prepared | December 12, 1997 |
| Device Trade Name | PhotoLight System |
| Common Name | High intensity flashlamp system |
| Classification Name | Instrument, surgical, powered, laser 79-GEX 21 CFR 878.4810 |
| Equivalent Device | The PhotoDerm VL by ESC Medical Systems |
| Device Description | The PhotoLight pulsed light system is a medical device utilizing optical energy for photocoagulation of vascular lesions |
| Intended Use | For the treatment of benign cutaneous vascular lesions |
| Comparison | The PhotoLight is substantially equivalent to the PhotoDerm VL in terms of treatment parameters used and also the intended uses |
| Nonclinical Performance Data | None |
| Clinical Performance Data | None |
| Conclusion | The PhotoLight System is another safe and effective way to treat vascular lesions |

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 9 1998

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

Re: K974674 Cynosure PhotoLight Flashlamp Trade Name: Regulatory Class: II Product Code: GEZ and KNS Dated: April 3, 1998 ________________________________________________________________________________________________________________________________________________________ Received: April 6, 1998

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 aqainst 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 requlation may result in regulatory In addition, FDA may publish further announcements action. 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. 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): __K97 4674

Device Name: Cynosure PhotoLight System

Indications for Ue:

The PhotoLight System is indicated for the treatment of benign cutaneous vascular lesions.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

OR

Over-The Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

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