POLARIS WR, ST APPLICATOR

K053616 · Syneron Medical, Ltd. · GEX · Mar 14, 2006 · General, Plastic Surgery

Device Facts

• Record ID: K053616
• Device Name: POLARIS WR, ST APPLICATOR
• Applicant: Syneron Medical, Ltd.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Mar 14, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Polaris WR, ST applicator is indicated for non invasive wrinkles treatment.

Device Story

The Polaris WR, ST applicator is a non-invasive device for wrinkle treatment. It utilizes the principle of selective electromagnetic thermolysis, combining optical and radiofrequency (RF) energy to heat skin tissue while sparing the epidermis. The device is operated by a clinician in a professional setting. The primary modification from the predicate is an expansion of the output wavelength spectrum from 780-980 nm to 700-2000 nm. The device is intended to improve skin appearance by reducing wrinkles through controlled thermal effects.

Clinical Evidence

No clinical data provided; the submission relies on the substantial equivalence of the modified device to the predicate based on the unchanged fundamental technology.

Technological Characteristics

Non-invasive device utilizing selective electromagnetic thermolysis. Combines optical and RF energy. Output wavelength spectrum: 700-2000 nm. Class II device (Product Codes: GEX, GEI).

Indications for Use

Indicated for non-invasive wrinkle treatment in 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

• Polaris WR (K031671)

Submission Summary (Full Text)

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K053616

## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

SYNERON MEDICAL Ltd. Polaris WR / ST Applicator

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., Tavor Bld., Submitter: Industrial Zone Yokneam Illit, Israel

Tel. [phone], Fax [phone]

Name of the Device: Polaris WR, ST Applicator

This is a Special 510(k) for the Polaris WR that was cleared Predicate Devices: under K031671.

Device Description: The Polaris WR is a device that is used for non invasive wrinkle treatment. The Polaris WR treatment is based on the principle of selective (electromagnetic) thermolysis. According to this principle, parameters of optical and RF energy (spectrum, exposure duration and energy density) are chosen and optimized to selectively heat the skin without damaging the epidermis layer.

The Polaris WR is intended for non invasive wrinkle treatment.

The modifications to the Polaris WR, ST applicator do not affect the intended use or alter the fundamental scientific technology of the device. The only device modification is changing the output wavelengths spectrum from 780-980 nm in the original Polaris WR to 700 - 2000 nm on the new Polaris WR, ST applicator.

There are no labeling changes that affect the intended use of the device. The device modifications raise no new issues of safety or effectiveness.

December 22 2005

Dr. Amir Waldman

Amir Waldren

VP regulatory & clinical affairs Syneron Medical Ltd.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol is a stylized representation of a bird or an abstract human figure with outstretched arms. The logo is presented in black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 4 2006

Syneron Medical LTD c/o Dr. Amir Waldman VP. Regulatory Affairs Sultam Industrial Park P.O. Box 550 Yokneam Elite 20692. Israel

Re: K053616

Trade/Device Name: Polaris WR, ST Applicator 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, GEI Dated: February 23, 2006 Received: February 24, 2006

Dear Dr. Waldman:

We have reviewed your Scction 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. Iisting 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 vour 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 nean 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 – Dr. Waldman

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 (800) 638-204) or [phone] or at its Internet address http://www.fda.gov/cdrh/dsmadsmamain.html

Sincerely yours,

Q.Mell

~ Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Image /page/3/Picture/0 description: The image shows the logo for Syneron Medical Ltd. The word "Syneron" is in a bold, sans-serif font, with the "S" stylized with a curved line extending from the top left. Below "Syneron" is the text "Medical Ltd." in a smaller, sans-serif font.

Sultam Industrial Park P.O.B. 550 Yokneam Elite 20692, Israel Tel: [phone] Fax: [phone]

510(k) Number (if known) K053616.

Device Name

## Indications For Use:

The Polaris WR, ST applicator is indicated for non invasive wrinkles treatment.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use_ (Per 21 CFR 801.109)

OR

Over The Counter Use__________________________________________________________________________________________________________________________________________________________

lmal

(Optional Format 1-2-96)

(Division Sign-Of Division of General, Restorative, and Neurological Devices

510(k) Number_ Ko 5 361 6