MODIFICATION TO VELASMOOTH, SHAPER

K070092 · Syneron Medical, Ltd. · NUV · Jul 27, 2007 · General, Plastic Surgery

Device Facts

• Record ID: K070092
• Device Name: MODIFICATION TO VELASMOOTH, SHAPER
• Applicant: Syneron Medical, Ltd.
• Product Code: NUV · General, Plastic Surgery
• Decision Date: Jul 27, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The VelaSmooth, Shaper is indicated for temporary reduction of thighs circumferences.

Device Story

VelaSmooth, Shaper applies simultaneous heat and mechanical manipulation to tissue. Heat source: infrared light energy and conducted RF energy. Mechanical manipulation source: massage and/or vacuum. Device used in clinical settings by trained operators. Output: physical tissue treatment. Clinical benefit: temporary reduction of thigh circumference.

Clinical Evidence

No clinical data provided; substantial equivalence based on performance characteristics and comparison to predicate device.

Technological Characteristics

Simultaneous application of infrared light energy, conducted RF energy, and mechanical manipulation (massage/vacuum). Class II device, product code NUV.

Indications for Use

Indicated for temporary reduction of thigh circumference in patients seeking cosmetic body contouring.

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

• VelaSmooth, Shaper (K050397)

Submission Summary (Full Text)

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070092

## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS SYNERON MEDICAL Ltd. VELASMOOTH, SHAPER

This summary of safety and effectiveness information is being submitted in accordance with the requirements of the SMDA 1990 and 21 CFR 807.92.

Syneron Medical Ltd., Industrial Park, P.O.B. 550, Yokneam Submitter: Illit, 20692, Israel.

Tel. [phone] ext. 591, Fax [phone]

Name of the Device: VelaSmooth. Shaper

- Predicate Devices: VelaSmooth, Shaper is substantially equivalent to the following VelaSmooth, Shaper laser surgical device: instrument, manufactured by Syneron Medical Ltd. and subject of K050397.
- Device Description: The VelaSmooth, Shaper treatment is based on the simultaneous application of heat and mechanical manipulation to the tissue, wherein the heat is derived from light energy at a controlled infrared wavelength and from conducted RF energy, and the mechanical manipulation is derived from massage and/or vacuum.

The VelaSmooth, Shaper is indicated for temporary reduction of thighs circumferences.

Based upon an analysis of the overall performance characteristic for the device, Syneron Medical Ltd. believes that no significant differences exit. Therefore the VelaSmooth, Shaper should raise no new issues of safety or effectiveness.

January 4, 2007

Yani I.

Date

Yoni Iger, Ph.D. Director of Clinical and Regulatory Affairs Syneron Medical Ltd.

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the seal is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Syneron Medical Limited % Yoni Iger, Ph.D. Director of Clinical and Regulatory Affairs Industrial Zone P.O. Box 550, Yokneam Illit 20692. Israel

JUL 27 2007

Re: K070092

Trade/Device Name: VelaSmooth, Shaper 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: NUV Dated: April 4, 2007 Received: May 21, 2007

Dear Dr. Iger:

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

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Page 2 - Yoni Iger, Ph.D.

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.

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,
Mark A. Millken

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)__ Ko 700 9 2

Device Name VelaSmooth, Shaper.

Indications For Use:

The VelaSmooth, Shaper is indicated for temporary reduction of thighs circumferences.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

Over The Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

Mark A. Millhurn

(Division Sign-Off) (Division of General, Restorative, and Neurological Devices

**510(k) Number** *_*_