CYNOSURE PHOTOGENICA SV LASER

K032539 · Cynosure, Inc. · GEX · Nov 17, 2003 · General, Plastic Surgery

Device Facts

• Record ID: K032539
• Device Name: CYNOSURE PHOTOGENICA SV LASER
• Applicant: Cynosure, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Nov 17, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The PhotoGenica sV laser is indicated for vascular and vascular dependent lesions of the upper airway including, but not limited to, glottal dysplasia, laryngeal papillomas and haemorrhagic telangiectasia.

Device Story

PhotoGenica sV is a pulsed-dye laser system utilizing organic dye as the lasing medium. It emits laser energy at a 585nm wavelength. The device is operated by a clinician via a footswitch. It is designed for the treatment of vascular and vascular-dependent lesions of the upper airway. By delivering targeted laser energy, the device enables the ablation or coagulation of specific tissue lesions. The system is a floor-standing unit weighing 285 lbs with dimensions of 44"x19"x24".

Clinical Evidence

No clinical data provided.

Technological Characteristics

Pulsed-dye laser; organic dye lasing medium; 585nm wavelength; footswitch activation; 110/220 VAC, 20A, 50-60 Hz power requirement; dimensions 44"x19"x24"; weight 285 lbs.

Indications for Use

Indicated for patients with vascular and vascular-dependent lesions of the upper airway, including glottal dysplasia, laryngeal papillomas, and haemorrhagic telangiectasia.

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

• PhotoGenica V
• PhotoGenica sV

Submission Summary (Full Text)

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

## NOV 17 2003

:

## 510(K) Summary

| | K032539 |
|-------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 15, 2003 |
| Device Trade Name: | PhotoGenica sV |
| Common Name: | Medical Laser System |
| Classification Name: | Instrument, surgical, powered, laser<br>79-GEX<br>21 CFR 878.48 |
| Equivalent Device: | PhotoGenica V and PhotoGenica sV |
| Device Description: | The PhotoGenica sV is a pulse-dye laser, having the organic dye as the<br>lasing medium. It is a pulsed dye laser with a wavelength of 585nm.<br><br>Laser activation is by footswitch. Overall weight of the laser is 285lbs,<br>and the size is 44"x19"x24" (HxWxD).<br><br>Electrical requirement is 110 VAC or 220 VAC, 20A, 50-60 Hz,<br>single phase. |
| Intended Use: | The PhotoGenica sV is indicated for treatment of vascular and vascular<br>dependent lesions of the upper airway. |
| Comparison: | The PhotoGenica sV laser has an equivalent indication for uses, the<br>same principle of operation, the same wavelength and pulse energy<br>range as the predicate devices. |
| Nonclinical Performance Data: | none |
| Clinical Performance Data: | none |
| Conclusion: | The PhotoGenica sV laser is another safe and effective device for soft<br>tissue applications. |
| Additional Information: | none |

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are black and are set against a white background. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the image.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 17 2003

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

Re: K032539 Trade/Device Name: PhotoGenica sV Laser 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: August 15, 2003 Received: August 19, 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. Ilisting 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.

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

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]. 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 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

forCelia 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

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

Page 1 of 1

510(k) Number (if known):

Device Name: Cynosure PhotoGenica sV Laser

Indications For Use:

The PhotoGenica sV laser is indicated for vascular and vascular dependent lesions of the upper airway including, but not limited to, glottal dysplasia, laryngeal papillomas and haemorrhagic telangiectasia.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

K032539

iriam C. Provost

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number --

Prescription Use

Over-The-Counter Use_