VELASHAPE

K122579 · Syneron Medical, Ltd. · NUV · Sep 13, 2012 · General, Plastic Surgery

Device Facts

• Record ID: K122579
• Device Name: VELASHAPE
• Applicant: Syneron Medical, Ltd.
• Product Code: NUV · General, Plastic Surgery
• Decision Date: Sep 13, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The VelaShape is indicated for the relief of minor muscle aches and pain, relief of muscle spasm, temporary improvement of local blood circulation, temporary reduction in the appearance of cellulite, and for temporary reduction of thighs circumferences.

Device Story

VelaShape system applies simultaneous heat and mechanical manipulation to tissue. Heat is generated via infrared (IR) light (LED source) and conducted radio frequency (RF) energy; mechanical manipulation is provided by massage and vacuum. Device is used in clinical settings by trained operators. Output is applied directly to patient skin to treat muscle aches, spasms, and aesthetic concerns (cellulite, thigh circumference). Healthcare providers use the device to deliver therapeutic heat and massage, aiming to improve circulation and reduce localized tissue volume. Benefits include temporary symptomatic relief and cosmetic improvement.

Clinical Evidence

Bench testing only. Verification testing was performed to ensure the modified LED infrared light source is compatible with previously cleared specifications. No clinical data or electromagnetic/electrical safety testing was required for this modification.

Technological Characteristics

System utilizes simultaneous application of infrared (IR) light energy (LED source), conducted radio frequency (RF) energy, and mechanical manipulation (massage and vacuum).

Indications for Use

Indicated for individuals seeking relief from minor muscle aches, pain, and spasms, temporary improvement in local blood circulation, temporary reduction in cellulite appearance, and temporary reduction in thigh circumference.

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

• VelaShape (K071872)

Submission Summary (Full Text)

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i<122579

## 510(k) SUMMARY Syneron Medical Ltd's VelaShape System

SEP
13 2012

## Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

Syneron Medical Ltd. Industrial zone Yokneam Illit 20692 Israel Tel: [phone] Fax: [phone]

Contact Person: Sam Wade, Global Vice President, Regulatory Affairs

Contact details:

Tel: [phone] Ext. 330 Fax: [phone] E-mail: sam.wade(@candelalaser.com

Date Prepared: August 22, 2012

### Name of Device

VelaShape

#### Common or Usual Name

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

#### Classification Name

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

### Predicate Devices

This Special 510(k) for the modified VelaShape is substantially equivalent to the previously cleared VelaShape device (K071872) manufactured by Syneron Medical, Ltd.

### Intended Use / Indications for Use

The VelaShape is indicated for the relief of minor muscle aches and pain, relief of muscle spasm, temporary improvement of local blood circulation, temporary reduction in the appearance of cellulite, and for temporary reduction of thighs circumferences.

## Technological Characteristics

The VelaShape treatment is based on the simultaneous application of heat and mechanical

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manipulation to the tissue, wherein the heat is derived from light energy at a controlled infrared wavelength and from conducted radio frequency (RF) energy and the mechanical manipulation is derived from massage and/or vacuum.

# Performance Data

Minor hardware modifications were performed to support the change of the VelaShape system infrared (IR) light source. Verification testing was performed to evaluate this modification to ensure the performance of the new light source is compatible with the previously cleared specifications. Electromagnetic compatibility or electrical safety testing was not required to support this modification. Performance testing demonstrates that the VelaShape system performs according to specifications and functions as intended.

### Substantial Equivalence

The change of the IR light source from a tungsten halogen lamp to a light-emitting diode (LED) for the VelaShape does not affect the indications for use or alter the fundamental scientific technology background of the device, nor does it affect the mode of use. There are no labeling changes that affect the indications for use of the device. The modification of the IR light source to LED raises no new issues of safety or effectiveness.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS) of the United States. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare, with three overlapping lines forming the shape of a bird. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus.

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

Syneron Medical, Limited % Mr. Sam Wade Global Vice President, Regulatory Affairs Industrial Zone Tavor Building P.O.B. 550 Yokneam, Illit Israel 20692

Re: K122579

Trade/Device Name: VelaShape 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: MUV Dated: August 22, 2012 Received: August 30, 2012

Dear Mr. Wade:

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.

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

SEP 13 2012

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### Page 2 - Mr. Sam Wade

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/CDRH/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,

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 Use Statement

510(k) Number (if known): k122579

Device Name: VelaShape

Indications for Use:

The VelaShape is indicated for the relief of minor muscle aches and pain, relief of muscle spasm, temporary improvement of local blood circulation, temporary reduction in the appearance of cellulite, and for temporary reduction of thighs circumferences.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

# (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

# Concurrence of CDRH, Office of Device Evaluation (ODE)

Neil R. Padel for mxm

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

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510(k) Number. K122579

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