CYNOSURE PHOTOGENICA V-STAR LASER

K053608 · Cynosure, Inc. · GEX · Feb 13, 2006 · General, Plastic Surgery

Device Facts

• Record ID: K053608
• Device Name: CYNOSURE PHOTOGENICA V-STAR LASER
• Applicant: Cynosure, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Feb 13, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Cynosure PhotoGenica V-Star Laser is indicated for benign vascular and vascular dependent lesion removal, and the treatment of benign epidermal pigmented lesions.

Device Story

Pulse dye laser system using organic dye as lasing medium; intended for photocoagulation of vascular lesions and treatment of pigmented lesions/skin conditions. Device weighs 285 lbs; dimensions 44"x19"x24"; requires 220 VAC power. Operated by clinician via footswitch or finger switch. Laser energy targets specific cutaneous structures to achieve therapeutic effect. Used in clinical settings for dermatology, plastic surgery, and related specialties. Output is laser energy; clinical benefit derived from lesion removal or skin condition treatment.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Pulse dye laser; organic dye lasing medium. Electrical requirements: 220 VAC, 30A, 50-60 Hz, single phase. Form factor: 44"x19"x24" floor-standing unit. Activation via footswitch or finger switch.

Indications for Use

Indicated for benign cutaneous vascular and vascular dependent lesions (e.g., facial/leg telangiectasia, rosacea, port wine stains, hemangiomas, angioma, spider angioma, Poikiloderma of Civatte), benign cutaneous lesions (e.g., warts, scars, striae, psoriasis), wrinkles, inflammatory acne vulgaris, and benign epidermal pigmented lesions. Used in general surgery, dermatology, plastic surgery, gynecology, and podiatry.

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

• Cynosure PhotoGenica VLS-Star Laser

Submission Summary (Full Text)

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FEB ] 3 2006

## 510(K) Summary

| Submitter: | Cynosure, Inc.<br>5 Carlisle Road<br>Westford, MA 01886 |
|-------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | George Cho<br>Senior Vice President of Medical Technology |
| Date Summary Prepared: | December 21, 2005 |
| Device Trade Name: | Cynosure PhotoGenica V-Star Laser |
| Common Name: | Medical Laser System |
| Classification Name: | Instrument, surgical, powered, laser<br>79-GEX<br>21 CFR 878.4810 |
| Equivalent Device: | Cynosure PhotoGenica VLS-Star Laser |
| Device Description: | The Cynosure PhotoGenica V-Star laser is a pulse dye laser, having an<br>organic dye as a lasing medium.<br><br>Laser activation is by footswitch or finger switch. Overall weight of<br>the laser is 285lbs, and the size is 44×19"×24" (HxWxD). |
| | Electrical requirement is 220 VAC. 30A. 50-60 Hz. single phase. |
| Intended Use: | The Cynosure PhotoGenica V-Star Laser is indicated for benign<br>vascular and vascular dependent lesion removal, and the treatment of<br>benign epidermal pigmented lesions. |
| Comparison: | The Cynosure PhotoGenica V-Star Laser has the same indications for<br>use, the same principle of operation, and similar wavelengths and<br>pulse energy range as the predicate device(s). |
| Nonclinical Performance Data: | none |
| Clinical Performance Data: | none |
| Conclusion: | The Cynosure PhotoGenica V-Star Laser is a safe and effective device<br>for the indications specified. |
| Additional Information: | none |

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three wavy lines representing the branches of government. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" is arranged in a circular pattern around the caduceus. The seal is simple and monochromatic.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 3 2006

Mr. George Cho Senior Vice President Medical Technology Cynosure, Inc. 5 Carlisle Road Westford, Massachusetts 01886

Re: K053608

Trade/Device Name: Cynosure PhotoGenica V-Star 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: December 22, 2005 Received: December 27, 2005

Dear Mr. Cho:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviews your be 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 10 devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, de noos marc 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 r va may, after story, mass 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 n may be sucject to basis 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 docs not mcan 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 or any I 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 Erth 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. Cho

This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to ocgin marketing your cover cever valence of your device to a legally premarket notification. "The PDT Intamig of casion 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 If you desire specific advice for your device of variation of the regulation entitled, Comaci the Office of Compunation at (21 CFR Part 807.97). You may obtain Misofanding by reference to premainters inibilities under the Act from the Division of Small other general intornational and Consumer Assistance at its toll-free number [phone] or Manufacturers, Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Barbara Buens
for

Mark N. Melkerson Acting 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): K 0 S > 6 D 8

Device Name: Cynosure PhotoGenica V-Star Laser

Indications For Use:

General Surgery: Photocoagulation of benign cutaneous vascular and vascular dependent lesions and benign cutaneous lesions.

Dermatology/Plastic Surgery: For treatment of benign cutaneous vascular lesions, such as facial

and leg telangiectasia, rosacea, port wine stains, hemangiomas, angioma, spider angioma, Poikiloderma of Civatte, and benign cutaneous lesions, such as warts, scars, striae and psoriasis and the treatment of wrinkles. Treatment of Benign Epidermal Pigmented Lesions.

Treatment of Inflammatory Acne Vulgaris

Gynecology: Photocoagulation of benign cutaneous lesions and benign vascular lesions in

gynecology.

Podiatry: Treatment of benign cutaneous lesions, such as warts.

Prescriptive Use X OR (Part 21 CFR 801 Subpart D)

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)

Chabare Buchum

Division of General, Restorative, and Neurological Devices

**510(k) Number** K053608