PHOTOSILK PULSED LIGHT SYSTEM

K041095 · Cynosure, Inc. · GEX · May 26, 2004 · General, Plastic Surgery

Device Facts

• Record ID: K041095
• Device Name: PHOTOSILK PULSED LIGHT SYSTEM
• Applicant: Cynosure, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: May 26, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Photosilk and Photosilk Plus systems are indicated for permanent hair reduction, and the treatment of benign vascular and pigmented lesions. The Photosilk and Photosilk Plus pulsed light system is indicated for permanent hair reduction. It is also indicated for photocoagulation of dermatological vascular lesions and the treatment of benign pigmented lesions. The integrated cooling handpiece is intended to provide pre-cooling of the epidermis, to reduce thermal injury and discomfort associated with light applications.

Device Story

Photosilk and Photosilk Plus are intense pulsed light (IPL) systems utilizing a Xenon flashlamp; wavelength range 400-1200nm. Device features integrated water-cooled handpiece for epidermal pre-cooling to reduce thermal injury/discomfort. Operated via foot switch by clinician in clinical setting. Light energy targets vascular and pigmented lesions via photothermolysis. System dimensions 103x50x48 cm; weight 65 kg; requires 220 VAC power. Output is pulsed light energy; clinical benefit includes hair reduction and lesion treatment.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Intense pulsed light (IPL) system; Xenon flashlamp source; 400-1200nm wavelength; integrated water-cooled handpiece for epidermal cooling; 220 VAC, 15A, 50-60 Hz power; 103x50x48 cm dimensions; 65 kg weight; foot switch activation.

Indications for Use

Indicated for permanent hair reduction, photocoagulation of dermatological vascular lesions, and treatment of benign pigmented lesions in patients requiring dermatological light-based 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

• Photolight PL system

Submission Summary (Full Text)

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K041095

## MAY 2 6 2004

## 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: | April 26, 2004 |
| Device Trade Name: | Photosilk and Photosilk Plus |
| Common Name: | Intense pulsed light system |
| Classification Name: | Instrument, surgical, powered, laser<br>79-GEX<br>21 CFR 878.48 |
| Equivalent Device: | Photolight PL system |
| Device Description: | Photosilk and Photosilk Plus are intense pulsed light systems, having a<br>Xenon flashlamp located in the handpieces. It is a light source with a<br>wavelength range of approximately 400 - 1200nm.<br>Light emission activation is by foot switch. Overall weight of the laser<br>is 65 Kg, and the size is 103x50x48 cm (HxWxD).<br>Electrical requirement is 220 VAC, 15A, 50-60 Hz, single phase.<br>Skin cooling is provided by the integrated cooling handpiece that<br>contains cooled water circulated through the handpiece body, the face<br>of which is in contact with the skin. |
| Intended Use: | The Photosilk and Photosilk Plus systems are indicated for permanent<br>hair reduction, and the treatment of benign vascular and pigmented<br>lesions. |
| Comparison: | The Photosilk and Photosilk Plus are substantially equivalent to the<br>Photolight PL, with the same principle of operation, the same<br>wavelength and essentially the same power range as the predicate<br>device for the same indications for uses. |
| Nonclinical Performance Data: | none |
| Clinical Performance Data: | none |
| Conclusion: | The Photosilk and Photosilk Plus are another safe and effective device<br>for permanent hair reduction, and treatment of benign vascular and<br>pigmented lesions. |
| Additional Information: | none |

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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 is circular in shape and features the department's name around the perimeter. In the center of the circle is a stylized image of an eagle with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## MAY 2 6 2004

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

Re: K041095

Trade/Device Name: Photosilk and Photosilk Plus 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: April 26, 2004 Received: April 27, 2004

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 cither 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 madc 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 clectronic 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) I his letter will and in Jourse FDA finding of substantial equivalence of your device to a legally premium to hotification. " 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 in you attire 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 other general 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 yours,

l. Mark A. Millheusen

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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510(k) Number (if known):

K041095

Device Name: Photosilk and Photosilk Plus pulsed light system

Indications For Use:

The Photosilk and Photosilk Plus pulsed light system is indicated for permanent hair reduction. It is also The Photostik and Photosik I las pulsed itgated as a lesions, photothermolysis of blood vessels
indicated for photocoagulation of dermatological vascular lesions and lovens marcated for photocougatures of and the treatment of benign pigmented lesions.

The integrated cooling handpiece is intended to provide pre-cooling of the epidenmis, to reduce thermal I he illtegrated coomig indicpless is meetieve with and discomfort associated with light applications.

N Prescription Use _ (Part 21 CFR 801 Subpart D) ાર

Over-The-Counter Use (Part 21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark N Milhersan

. Restorative, and Neurological Devices

510(k) Number K091095