CYNOSURE ACCLAIM DERMATOLOGY LASER

K011828 · Cynosure, Inc. · GEX · Sep 7, 2001 · General, Plastic Surgery

Device Facts

• Record ID: K011828
• Device Name: CYNOSURE ACCLAIM DERMATOLOGY LASER
• Applicant: Cynosure, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Sep 7, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Cynosure Acclaim Dermatology Laser is indicated for the treatment of benign cutaneous vascular lesions and hair removal.

Device Story

Acclaim Dermatology Laser is a pulsed solid-state laser emitting at 1064nm (near-infrared). Device is used in clinical settings by trained professionals for dermatologic applications, specifically benign vascular lesions and hair removal. Laser activation is controlled via finger switch or footswitch. System is a floor-standing unit weighing 285 lbs with dimensions 44"x19"x24". Electrical power is 110/220 VAC. Device functions by delivering laser energy to target tissue; clinical benefit is achieved through the therapeutic effects of the 1064nm wavelength on vascular structures and hair follicles.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Pulsed solid-state laser; 1064nm wavelength; 110/220 VAC, 20A, 50-60 Hz power; 285 lbs; 44"x19"x24" dimensions; finger/footswitch activation.

Indications for Use

Indicated for the treatment of benign cutaneous vascular lesions and hair removal in patients requiring dermatologic laser 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

• Cynosure PhotoGenica DL Laser
• Altus Medical Aesthetic Nd:YAG Laser

Submission Summary (Full Text)

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## SEP - 7 2001

Submitter:

Contact:

Date Summary Prepared:

Common Name:

Classification Name:

Device Trade Name:

Equivalent Device:

Device Description:

Intended Use:

Comparison:

Nonclinical Performance Data: Clinical Performance Data:

Conclusion:

Additional Information:

## 510(k) SUMMARY

## - 0118 27

Cynsoure, Inc. 10 Elizabeth Drive Chelmsford, MA 01824

George Cho Senior Vice President of Medical Technology

June 11, 2001

Acclaim Dermatology Laser

Medical Laser System

Instrument, surgical, powered, laser 79-GEX 21 CFR 878.48

Cynosure PhotoGenica DL Laser and Altus Medical Aesthetic Nd:YAG Laser.

The Acclaim is a pulsed solid state laser, emitting at the near intra-red wavelength of 1064nm.

Laser activation is both by finger switch and footswitch. Overall weight of the laser is 285lbs, and the size is 44"x19"x24" (HxWxD).

Electrical requirement is 110 VAC or 220 VAC, 20A, 50-60 Hz, single phase.

The Acclaim Dermatology Laser is indicated for benign vascular lesions and hair removal.

The Acclaim Dermatology Laser has the same indication for uses, the same principle of operation, the same wavelength and pulse energy range as the predicate devices.

none

none

The Acclaim Dermatology Laser is another safe and effective device for dermatologic applications.

none

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP - 7 2001

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

Re: K011828

Trade/Device Name: Cynosure Acclaim Dermatology Laser Regulation Number: 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 11, 2001 Received: June 12, 2001

Dear Mr. Cho:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations (1 remarrer ripps of the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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## Page 2 - Mr. George Cho

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at additionally 00911 o ditionally, 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small monmation on your respond and Consumer Assistance at its toll-free number [phone] or 1101) 443-6597 or at its internet address "http://www.fda.gov/cdrb/dsma/dsmamain.html".

Sincerely yours,

Lis Walker, up

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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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501(k) Number (if known):

KO11828

Device Name:

Cynosure Acclaim Dermatology Laser

Indications For Use:

The Cynosure Acclaim Dermatology Laser is indicated for the treatment of benign cutaneous vascular lesions and hair removal.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)


(Division Sign-Off) (Division Sign-OII)
Division of General, Restorative
Division of General Devices Division of Genological Devices

510(k) Number K011828

Prescription Use (Per 21 CFR 801.109) OR

Over-the-Counter Use

(Optional Format 1-2-96)