SMARTLIPO ND:YAG LASER

K062321 · Cynosure, Inc. · GEX · Oct 31, 2006 · General, Plastic Surgery

Device Facts

• Record ID: K062321
• Device Name: SMARTLIPO ND:YAG LASER
• Applicant: Cynosure, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Oct 31, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SmartLipo Laser is intended for the surgical incision, vaporization, ablation, and coagulation of soft tissue. All soft tissue is included, such as skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs and glands. The SmartLipo is further indicated for laser assisted lipolysis.

Device Story

SmartLipo Nd:YAG laser system; emits 1064nm wavelength for soft tissue surgery and laser-assisted lipolysis. Operated by physician via foot switch. System dimensions 65" x 23" x 68"; weight 180 lbs; requires 230 VAC power. Laser energy facilitates incision, excision, vaporization, ablation, and coagulation of various soft tissues including skin, muscle, and glands. Clinical benefit derived from precise tissue interaction during surgical procedures and lipolysis.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Nd:YAG laser system; 1064nm wavelength; foot switch activation; 230 VAC, 15A, 50-60 Hz power requirement; 180 lbs; 65" x 23" x 68" form factor.

Indications for Use

Indicated for surgical incision, vaporization, ablation, and coagulation of soft tissues (skin, muscle, cartilage, organs, glands, etc.) and laser-assisted lipolysis in patients requiring such procedures.

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

• Laserscope Lyra Series Nd: Y AG Laser system

Submission Summary (Full Text)

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## 1-062321

## 510(K) Summary

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Device Trade Name:

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Nonclinical Performance Data: Clinical Performance Data: Conclusion:

Additional Information:

Cynosure, Inc. 5 Carlisle Road Westford, MA 01886

OCT 3 1 2006

George Cho Senior Vice President of Medical Technology

August 8, 2006

SmartLipo Nd: YAG Laser system

Nd: YAG laser

Instrument, surgical, powered, laser 79-GEX 21 CFR 878.4810

Laserscope Lyra Series Nd: Y AG Laser system

The SmartLipo Laser is a Nd: YAG laser system. It emits a 1064nm wavelength.

Laser emission activation is by foot switch. Overall weight of the laser is 180 lbs., and the size is 65" x 23" x 68" (LxWxH).

Electrical requirement is 230 VAC, 15A, 50-60 Hz, single phase.

The SmartLipo laser is intended for the surgical incision, excision, vaporization, ablation, and coagulation of soft tissue. All soft tissue is included, such as skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs and glands. The SmartLipo is further indicated for laser assisted lipolysis.

The SmartLipo laser system has the same indication for use, the same principle of operation, and essentially the same wavelength and pulse energy range as the predicate device.

none

none

The SmartLipo laser is a safe and effective device for the indicated uses.

none

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 3 1 2006

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

Re: K062321

Trade/Device Name: Cynosure SmartLipo 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: October 2, 2006 Received: October 3, 2006

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.

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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 vours

Mark N. Melkerson 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):

R 062321

Device Name: Cynosure SmartLipo Laser

Indications For Use:

The SmartLipo Laser is intended for the surgical incision, vaporization, ablation, and coagulation of soft tissue. All soft tissue is included, such as skin, cutaneous tissue, subcutaneous. tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs and glands. The SmartLipo is further indicated for laser assisted lipolysis.

> Prescriptive Use OR X (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)

Division of General, Restorative, and Neurological Devices

7100 Number Kd(232)