POLARIS DS

K024064 · Syneron Medical, Ltd. · GEX · Feb 10, 2003 · General, Plastic Surgery

Device Facts

• Record ID: K024064
• Device Name: POLARIS DS
• Applicant: Syneron Medical, Ltd.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Feb 10, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Polaris DS is indicated for non invasive hair removal.

Device Story

Polaris DS is a non-invasive device for hair removal. It utilizes the principle of selective electromagnetic thermolysis, combining optical and radiofrequency (RF) energy. By optimizing parameters such as spectrum, exposure duration, and energy density, the device selectively damages hair follicles while sparing surrounding tissues. It is intended for use in dermatology settings. The device is operated by healthcare professionals. The output is the delivery of targeted energy to the skin, which facilitates hair removal and provides a cosmetic benefit to the patient.

Clinical Evidence

No clinical data provided; substantial equivalence is based on analysis of overall performance characteristics and comparison to predicate devices.

Technological Characteristics

The device utilizes a combination of optical and radiofrequency (RF) energy to perform selective thermolysis. It is classified as a laser surgical instrument (21 CFR 878.4810, Product Code GEX).

Indications for Use

Indicated for non-invasive hair removal in patients requiring dermatological treatment.

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

• Aurora DS (K021149)
• SLP 1000 (K013028)
• PhotoGenica DL (K010005)
• Dornier Medilas D SkinPulse Laser (K003993)

Submission Summary (Full Text)

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024064 F

## FEB 1 0 2003

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

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 DS

Predicate Devices: The Polaris DS is substantially equivalent to a combination of four laser powered surgical instruments (21 CFR 878.4810, procode GEX): Aurora DS, manufactured by Syneron Medical Ltd. and subject of K021149; SLP 1000, manufactured by Palomar Medical Technologies Inc. and subject of K013028; PhotoGenica DL, manufactured by Cynosure Inc. and subject Dornier Medilas of K010005: D SkinPulse Laser. manufactured by DornierMedTech, and subject of K003993.

- Device Description: The Polaris DS is a device that is used for non invasive hair removal. The Polaris DS 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 damage to the hair follicle without damaging the surrounding tissues.
The Polaris DS is intended for use in dermatology for non invasive hair removal.

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

Dec. 1, 202

Air Waldman

Dr. Amir Waldman, Director regulatory affairs Syneron medical Ltd.

Date

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FEB 1 0 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Dr. Amir Waldman Director, Regulatory Affairs Syneron Medical Ltd. Sultam Industrial Park POB 550 Yokneam Elite Israel 20692

Re: K024064 Trade Name: Polaris DS 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: December 4, 2002 Received: December 9, 2002

Dear Dr. Waldman:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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 vours.

Sincerely yours,

Mark N Milliman

Celia M. Witten, Ph.D., M.D. 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) KO2 YOG4

Device Name___Polaris DS.

Indications For Use:

The Polaris DS is indicated for non invasive hair removal.

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

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 N. Millerson

of General, Restorative Neurolozical Devices

Number K02 4064