CYNOSURE CELLULAZE LASER

K102541 · Cynosure, Inc. · OYW · Jan 26, 2012 · General, Plastic Surgery

Device Facts

• Record ID: K102541
• Device Name: CYNOSURE CELLULAZE LASER
• Applicant: Cynosure, Inc.
• Product Code: OYW · General, Plastic Surgery
• Decision Date: Jan 26, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Cynosure Cellulaze Laser is intended for the short term improvement in the appearance of cellulite.

Device Story

Cynosure Cellulaze Laser is an Nd:YAG laser (1440nm) for cellulite treatment. System utilizes laser optical fiber housed within a cannula to deliver energy to subcutaneous tissue. Integrated temperature monitoring guide functions as safety feature to prevent overheating. Operated by physicians in clinical settings. Laser energy melts fat/tissue to improve cellulite appearance. Temperature monitoring ensures site temperature remains within safe range, preventing adverse thermal effects. Clinical efficacy demonstrated via blinded evaluation of pre/post-treatment photographs (3-month follow-up) and validated improvement scales. Safety profile established through clinical studies reporting common procedure-related events (pain, redness, swelling, etc.) which resolved without intervention.

Clinical Evidence

Clinical data from two studies (106 total subjects; 103 evaluated for safety, 57 for efficacy). Efficacy endpoints: blinded identification of baseline photographs (91-95% success, exceeding 80% threshold) and blinded evaluation of cellulite improvement (91% of sites met pre-specified improvement on validated scale). Safety data showed common adverse events (pain, redness, swelling, purpura, itching, numbness, blistering, hardness, seroma, necrosis) which resolved without medical intervention.

Technological Characteristics

Nd:YAG laser system; 1440nm wavelength. Energy delivery via optical fiber housed in a cannula. Integrated temperature monitoring guide for thermal safety control. Class II device.

Indications for Use

Indicated for the short-term improvement in the appearance of cellulite in adult patients.

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

• SmartLipo Multiwavelength with 1440nm Wavelength (K091537)

Submission Summary (Full Text)

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K102541

## 510(K) Summary

## Submitter:

Contact:

Cynosure, Inc. 5 Carlisle Road Westford, MA 01886

Irina Kulinets Vice President of Regulatory Affairs and Quality Systems

October 3. 2012

Cynosure Cellulaze Laser

Medical Laser System

Laser surgical instrument for use in general and plastic surgery and in dermatology

21 CFR 878.4810

SmartLipo Multiwavelength with 1440nm Wavelength, K091537

The Cynosure Cellulaze laser is an Nd: Y AG laser, with a wavelength of 1440nm. The energy delivering laser optical fiber is housed within a cannula and is combined with the temperature monitoring guide functioning as a safety feature that prevents the laser from generating temperature above the safety range.

The Cellulaze Laser is intended for the short term improvement in the appearance of cellulite.

The Cynosure Cellulaze Laser has similar intended use, the same principle of operation, and the same performance specifications as the predicate device. Additionally the same temperature monitoring device as in the predicate device is utilized to ensure temperature within the specified range.

The use of the temperature monitoring device to control site temperature is identical to how this same laser system is used for the prior clearance of fat lipolysis, both predicate device and Cellulaze rely on control temperature to produce fat melting without causing adverse effects associated with higher temperatures.

None

Clinical Performance Data:

Nonclinical Performance Data:

Data from two clinical studies enrolling a total of 106 subjects were provided to support safety and efficacy of the device.

JAN 2 6 2012

Common Name: Classification Name:

Equivalent Device:

Date Summary Prepared:

Device Trade Name:

Device Description:

Intended Use:

Comparison:

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| | The clinical dataset used to support the efficacy of the specific indication<br>for use was collected in a clinical study that enrolled 57 subjects. The<br>company provided data from two co-primary endpoints, ability of<br>blinded evaluators to correctly identify baseline photographs and<br>evaluation of improvement in the appearance of cellulite by blinded<br>evaluator scoring of pre and post treatment photographs. The blinded<br>evaluation was made using 3 month post-treatment photographs.<br><br>Success for identification of baseline photographs was at least 80% of<br>the photographs being correctly identified. For this endpoint the range<br>for the 3 evaluators was 91-95% which exceeded the predetermine<br>success criteria. |
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| | For the endpoint that evaluated improvement, success was established as<br>80% of the sites showing a pre-specified improvement on a validated<br>scale. Blinded evaluation of this endpoint showed 91% of the sites<br>meeting this requirement. |
| | A total of 103 subjects were evaluated for safety. Adverse events<br>reported in the two studies included pain, redness, swelling, purpura,<br>itching, numbness, blistering, hardness, seroma, and necrosis. These<br>types of adverse events are common to this type of procedure. All of<br>these events did resolve without need for medical intervention. |
| Conclusion: | The similarity in technical characteristics combined with the clinical<br>safety and effectiveness data demonstrate that the Cynosure Cellulaze<br>Laser is substantially equivalent to the predicate device for the<br>indication for use specified. |
| Additional Information: | None |

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Image /page/2/Picture/0 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle or bird with outstretched wings. The bird is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" surrounding it.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

JAN 2 6 2012

Cynosure, Inc. % Mr. George Cho Vice President, Medical Technology and Regulatory Affairs 5 Carlisle Road Westford, Massachusetts 01886

Re: K102541

Trade/Device Name: Cynosure Cellulaze Laser and Cellulaze Delivery Kit Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: Class II Product Code: OYW Dated: January 20, 2012 Received: January 23, 2012

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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Page 2 - Mr. George Cho

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go.to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,
Erin Keith

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and

Radiological Health

Enclosure

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## Indications For Usc

510(k) Number (if known): K102541

Device Name: Cynosure Cellulaze Laser

Indications For Use:

The Cynosure Cellulaze Laser is intended for the short term improvement in the appearance of cellulite.

Prescriptive Use _ X ( 21 CFR 801 Subpart D) OR, Over-The-Counter Use ( 21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Niels. Ryden for mkn

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number k102541