CYNERGY LASER

K043429 · Cynosure, Inc. · GEX · Jan 12, 2005 · General, Plastic Surgery

Device Facts

• Record ID: K043429
• Device Name: CYNERGY LASER
• Applicant: Cynosure, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Jan 12, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

585 - 600nm: The Cynergy laser is indicated for benign vascular and vascular dependant lesions removal. 1,064nm: The Cynergy laser is intended for the coagulation and hemostasis of benign vascular lesions such as, but not limited to, port wine stains, hemangiomas, warts, telangiectasia, rosacea, venus lakes, leg veins, spider veins, and poikiloderma of civatte and treatment of benign cutaneous lesions such as, but not limited to lentigos (age spots), solar lentigos (sun spots), café au lait manules, seborrheic keratoses, nevi, chloasma, verrucea, skin tags, keratoses, tattoos (significant reduction in the intensity of black and/or blue/black tattoos) and plaques. The laser is also indicated for the treatment of wrinkles such as, but not limited to, periocular and perioral wrinkles. Additionally, the laser is intended for the removal of unwanted hair, for the stable long term, or permanent, hair reduction through selective targeting of melanin in hair follicles, and for the treatment of psuedofolliculitis barbae (PFB).

Device Story

Cynergy Laser is a multi-wavelength medical laser system utilizing organic dye (585-600nm) and Nd:YAG (1,064nm) lasing media. Device operates via footswitch activation; delivers pulsed laser energy to target tissues. Used in clinical settings by trained professionals for dermatological procedures including vascular/pigmented lesion removal, tattoo reduction, wrinkle treatment, and hair removal. Principle of operation relies on selective photothermolysis to target melanin or vascular structures. System is a floor-standing unit (285 lbs, 41"x18"x32"). Output affects clinical decision-making by providing non-invasive therapeutic options for skin conditions; benefits patients through targeted tissue treatment and cosmetic improvement.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Multi-wavelength laser system; organic dye (585, 590, 595, 600nm) and Nd:YAG (1,064nm) media. Footswitch activation. Electrical: 110/220 VAC, 20A, 50-60 Hz. Dimensions: 41"x18"x32". Weight: 285 lbs.

Indications for Use

Indicated for patients requiring treatment of benign vascular lesions, pigmented lesions, tattoos, wrinkles, unwanted hair, and pseudofolliculitis barbae. Specific conditions include port wine stains, hemangiomas, telangiectasia, rosacea, leg veins, lentigos, café au lait macules, seborrheic keratoses, and periocular/perioral wrinkles.

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 TriStar laser

Submission Summary (Full Text)

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

K 043429

## JAN 1 2 2005

## 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: | December 9, 2004 |
| Device Trade Name: | Cynergy Laser |
| Common Name: | Medical Laser System |
| Classification Name: | Instrument, surgical, powered, laser<br>79-GEX<br>21 CFR 878.48 |
| Equivalent Device: | Cynosure TriStar laser |
| Device Description: | The Cynergy is a user selectable, multi wavelength laser, having both<br>an organic dye and an Nd:YAG rod lasing medium. It is a pulsed dye<br>laser with wavelengths of 585, 590, 595,600nm and an Nd:YAG laser<br>with a wavelength of 1,064nm. |
| | Laser activation is by footswitch. Overall weight of the laser is<br>285lbs, and the size is 41"x18"x32" (HxWxD). |
| | Electrical requirement is 110 VAC or 220 VAC, 20A, 50-60 Hz,<br>single phase. |
| Intended Use: | The Cynergy is indicated for treatment of vascular lesions, pigmented<br>lesions, tattoos, wrinkles and hair removal. |
| Comparison: | The Cynergy laser is substantially equivalent to the TriStar laser, with<br>the same indications for uses, the same principle of operation, and<br>similar wavelengths and fluence rangse as the predicate devices. |
| Nonclinical Performance Data: | none |
| Clinical Performance Data: | none |
| Conclusion: | The Cynergy laser is another safe and effective device for treating<br>vascular lesions, pigmented lesions, tattoos, wrinkles and hair removal |
| 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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles three abstract human figures or waves, arranged in a row.

Public Health Service

JAN 1 2 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K043429 Trade/Device Name: Cynergy 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 9, 2004 Received: December 13, 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 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/industry/support/index.html.

Sincerely yours,

Miriam C. Provost

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

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

## 043429 510(k) Number (if known):

Device Name: Cynosure Cynergy Laser

Indications For Use:

585 - 600nm: The Cynergy laser is indicated for benign vascular and vascular dependant lesions removal.

1,064nm: The Cynergy laser is intended for the coagulation and hemostasis of benign vascular lesions such as, but not limited to, port wine stains, hemangiomas, warts, telangiectasia, rosacea, venus lakes, leg veins, spider veins, and poikiloderma of civatte and treatment of benign cutaneous lesions such as, but not limited to lentigos (age spots), solar lentigos (sun spots), café au lait manules, seborrheic keratoses, nevi, chloasma, verrucea, skin tags, keratoses, tattoos (significant reduction in the intensity of black and/or blue/black tattoos) and plaques.

The laser is also indicated for the treatment of wrinkles such as, but not limited to, periocular and perioral wrinkles.

Additionally, the laser is intended for the removal of unwanted hair, for the stable long term, or permanent, hair reduction through selective targeting of melanin in hair follicles, and for the treatment of psuedofolliculitis barbae (PFB).

OR Over-The-Counter Use Prescriptive Use x (Part 21 CFR 801 Subpart D) (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)

Miriam C. Provost

**510(k) Number** k043429