CYNOSURE PHOTOLIGHT PL

K031258 · Cynosure, Inc. · GEX · Jul 8, 2003 · General, Plastic Surgery

Device Facts

• Record ID: K031258
• Device Name: CYNOSURE PHOTOLIGHT PL
• Applicant: Cynosure, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Jul 8, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Photolight PL is indicated for permanent hair reduction, photocoagulation of vascular lesions, photothermolysis of blood vessels, treatment of benign pigmented lesions. The CoolHand cooling device is intended to provide pre-cooling of the epidermis, to reduce thermal injury to the epidermis, and to reduce patient pain and discomfort associated with light applications.

Device Story

Photolight PL is an intense pulsed light (IPL) system utilizing a Xenon flashlamp; emits light in 400-1400 nm range. Device includes CoolHand cooling accessory for epidermal pre-cooling to mitigate thermal injury and patient discomfort. Operated by clinician via footswitch activation. System weighs 18 Kg; dimensions 20x48x54 cm. Used in clinical settings for dermatological procedures. Light energy targets vascular and pigmented lesions or hair follicles via photothermolysis. Output is controlled by clinician to achieve therapeutic effect.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Intense pulsed light (IPL) system; Xenon flashlamp source; 400-1400 nm wavelength range; 110 VAC, 15A, 50-60 Hz power; footswitch activation; includes CoolHand epidermal cooling device.

Indications for Use

Indicated for permanent hair reduction, photocoagulation of dermatological vascular lesions, photothermolysis of blood vessels (facial and leg veins), and treatment of benign pigmented lesions.

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

• EsteLux pulsed light system

Submission Summary (Full Text)

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**510(K) Summary**

K031258 - 10, 1

| Submitter: | Cynosure, Inc.<br>10 Elizabeth Drive<br>Chelmsford, MA 01824 |
|-------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | JUL 0 8 2003 |
| Contact: | George Cho<br>Senior Vice President of Medical Technology |
| Date Summary Prepared: | April 18, 2003 |
| Device Trade Name: | Photolight PL |
| Common Name: | Medical Laser System |
| Classification Name: | Instrument, surgical, powered, laser<br>79-GEX<br>21 CFR 878.48 |
| Equivalent Device: | EsteLux pulsed light system |
| Device Description: | Photolight PL is a intense pulsed light system, having a Xenon<br>flashlamp located in the handpieces. It is a light source with a range<br>approximately 400 - 1400 nm wavelength.<br>Emission activation is by footswitch. Overall weight of the laser is 18<br>Kg, and the size is 20x48x54 cm (HxWxD).<br>Electrical requirement is 110 VAC, 15A, 50-60 Hz, single phase. |
| Intended Use: | The Photolight PL is indicated for permanent hair reduction,<br>photocoagulation of vascular lesions, photothermolysis of blood<br>vessels, treatment of benign pigmented lesions.<br>The CoolHand cooling device is intended to provide pre-cooling of the<br>epidermis, to reduce thermal injury to the epidermis, and to reduce<br>patient pain and discomfort associated with light applications. |
| Comparison: | The Photolight PL system has an equivalent indication for uses, the<br>same principle of operation, and essentially the same wavelength<br>range and pulse energy range as the predicate device. |
| Nonclinical Performance Data: | none |
| Clinical Performance Data: | none |
| Conclusion: | The Photolight PL is another safe and effective device for permanent<br>hair reduction, photocoagulation of vascular lesions, photothermolysis<br>of blood vessels, treatment of benign 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 features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The symbol is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. The text is written in a simple, sans-serif font.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## JUL 0 8 2003

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

Re: K031258 Trade/Device Name: Cynosure Photolight PL 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: June 12, 2003 Received: June 13, 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]. 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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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 yours,

Miriam C. Provost

for 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): _ K031258

Device Name: Cynosure Photolight PL

Indications For Use:

The Photolight Pulsed Light device is indicated for permanent hair reduction. It is also indicated for photocoagulation of dermatological vascular lesions, photothermolysis of blood vessels (treatment of facial and leg veins), and the treatment of benign pigmented lesions.

The CoolHand cooling device is intended to provide pre-cooling of the epidermis, to reduce thermal injury to the epidermis, and to reduce patient pain and discomfort associated with light applications.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Miriam C. Provost

neral, Restorative and Neurological Devices

510(k) Number K031258

Prescription Use

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OR

Over-The-Counter Use