POLARIS WR

K031671 · Syneron Medical, Ltd. · GEX · Dec 1, 2003 · General, Plastic Surgery

Device Facts

• Record ID: K031671
• Device Name: POLARIS WR
• Applicant: Syneron Medical, Ltd.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Dec 1, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Polaris WR is intended for use in dermatology for non ivasive wrinkles treatment.

Device Story

Polaris WR is a dermatological device for non-invasive wrinkle treatment. It utilizes the principle of selective electromagnetic thermolysis, combining optical and RF energy. By optimizing parameters such as spectrum, exposure duration, and energy density, the device selectively damages target tissue while sparing surrounding areas. The device is intended for clinical use by healthcare professionals. The output is delivered directly to the skin to achieve therapeutic effects, aiding in the reduction of wrinkles.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and performance analysis.

Technological Characteristics

Device utilizes combined optical and RF energy for selective electromagnetic thermolysis. Parameters include adjustable spectrum, exposure duration, and energy density. Class II device under 21 CFR 878.4810 and 878.4400.

Indications for Use

Indicated for non-invasive wrinkle treatment in dermatology 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 LV (K030186)
• Coolglide (K023954)
• ThermaCool TC (K030142)

Submission Summary (Full Text)

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K03167|

## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS SYNERON MEDICAL Ltd. POLARIS WR

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

| Submitter: | Syneron Medical Ltd., Sultam Industrial park, P.O.B. 550,<br>Yokneam Elite 20692, Israel.<br>Tel. [phone] ext. 7604, Fax [phone] |
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Name of the Device: Polaris WR

- Predicate Devices: The Polaris WR is substantially equivalent to a combination of 3 laser powered surgical instruments (21 CFR 878.4810, procode GEX): Polaris LV, manufactured by Syneron Medical Ltd. and subject of K030186; Coolglide, manufactured by Altus Medical Inc. and subject of K023954; ThermaCool TC, Manufactured by Thermage Inc. and subject of K030142.
- Device Description: The Polaris WR is a device that is used for non invasive wrinkles treatment. The Polaris WR treatment is based on the principle of selective (electromagnetic) thermolysis. According to this principle, parameters of optical and RF cnergy (spectrum, exposure duration and energy density) are chosen and optimized to selectively damage to the treatment target without damaging the surrounding tissues.

The Polaris WR is intended for use in dermatology for non ivasive wrinkles treatment.

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

September, 4,2003

Amir Walden

Dr. Amir Waldman, Director regulatory 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 is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem featuring a stylized caduceus, which is a symbol often associated with healthcare and medicine.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC = 1 2003

Dr. Amir Waldman Director, Regulatory Affairs Syneron Medical Ltd. Sultam Industrial Park P.O.B. 550 Yokneam Elite 20692, Isracl

Re: K031671 Trade/Device Name: Polaris WR Regulation Number: 21 CFR 878.4810, 878.4400 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology; Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEX, GEI Dated: September 4, 2003 Received: September 8, 2003

Dear Dr. Waldman:

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 - Dr. Amir 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours.

Miriam C. Provost

W Cclia M. Witten, Ph.D., M.I). 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) K031671.

Device Name___Polaris WR.

Indications For Use:

The Polaris WR is indicated for non invasive wrinkles treatment.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use_L (Per 21 CFR 801.109) OR '

Over The Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

Miriam C. Provost

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

510(k) Number K031671