POLARIS DS/COMET

K041959 · Syneron Medical, Ltd. · GEX · Nov 8, 2004 · General, Plastic Surgery

Device Facts

• Record ID: K041959
• Device Name: POLARIS DS/COMET
• Applicant: Syneron Medical, Ltd.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Nov 8, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Polaris DS / Comet is indicated for hair removal, permanent hair reduction. The Polaris DS / Comet is intended for use on all skin types, (Fitzpatrick skin type I-VI), including tanned skin.

Device Story

The Polaris DS / Comet is a surgical instrument used for hair removal and permanent hair reduction. It operates on the principle of selective electromagnetic thermolysis, utilizing a combination of 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 tissue. It is intended for use on all skin types, including tanned skin. The device is operated by healthcare professionals in a clinical setting. The provider uses the device to deliver targeted energy to the skin surface to achieve hair reduction, potentially benefiting the patient through long-term hair removal.

Clinical Evidence

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

Technological Characteristics

The device utilizes selective electromagnetic thermolysis combining optical and radiofrequency energy. It is classified as a laser surgical instrument (21 CFR 878.4810) and electrosurgical device (21 CFR 878.4400).

Indications for Use

Indicated for hair removal and permanent hair reduction in patients of all skin types (Fitzpatrick I-VI), including tanned skin.

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 DS (K024064)
• Polaris WR (K031671)
• LightSheer (K003614)
• Mythos 500 (K030805)

Submission Summary (Full Text)

{0}------------------------------------------------

K041959

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

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., Sultam Industrial park, P.O.B. 550, Submitter: Yokneam Elite 20692, Israel. Tel. [phone] ext. 7604, Fax [phone]

Name of the Device: Polaris DS / Comet

- The Polaris DS /Comet is substantially equivalent to a Predicate Devices: combination of four laser powered surgical instruments (21 CFR 878.4810, procode GEX): Polaris DS, manufactured by Syneron Medical Ltd. and subject of K024064. Polaris WR, manufactured by Syneron Medical Ltd. and subject of K031671. LightSheer, manufactured by Lumenis Inc. and subject of K003614. Mythos 500, manufactured by Msq Ltd. and subject of K030805
- Device Description: The Polaris DS / Comet is a device indicated for hair removal, permanent hair reduction. The Polaris DS is intended for use on all skin types, (Fitzpatrick skin type I-VI), including tanned skin. The Polaris DS / Comet 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 hair removal, permanent hair reduction. The Polaris DS is intended for use on all skin types, (Fitzpatrick skin type I-VI), including tanned skin.

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

July 15 2007

Amelia Weber

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

Date

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image is a circular seal or logo. The seal contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is a stylized image of an eagle or bird-like figure with three curved lines representing its body and wings. The overall design is simple and monochromatic.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 8 2004

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

Re: K041959 Trade/Device Name: Polaris DS / Comet Regulation Number: 21 CFR 878.4810, 21 CFR 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: October 21, 2004 Received: October 25, 2004

Dear Dr. Waldman:

We have reviewed your Section 510(k) premarket notification of intent to market the device wt nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 101 use stated in the encrobare) to regary to regars and the Medical Device Amendments, or to conninered province with the provisions with the provisions of the Federal Food, Drug, de necs that have been require approval of a premarket approval application (PMA). and Cosmeter Act (1107 market the device, subject to the general controls provisions of the Act. The r ou may, dictions provisions of the Act include requirements for annual registration, listing of general bonus provisions of visitive, 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 If your device to such additional controls. Existing major regulations affecting your device can may or subject to back additions, 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 I tease be activities that I Driseanter over device complies with other requirements of the Act that I Dri has Intacted and regulations administered by other Federal agencies. You must of any I cataled and registments, including, but not limited to: registration and listing (21

{2}------------------------------------------------

## Page 2 - Dr. Amir Waldman

CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set OI It I all 607); adoling (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (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) This icher will anow you to organ finding of substantial equivalence of your device to a legally prematicate 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 If you desire specific advice 10. 900 and 11. Also, please note the regulation entitled, Contact the Office or Comparket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other geleral informational 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

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

{3}------------------------------------------------

510(k) Number (if known)_ K_041959

Device Name___ Polaris DS / Comet.

## Indications For Use:

The Polaris DS / Comet is indicated for hair removal, permanent hair The Fouris DS / Comet is intended for use on all skin types, (Fitzpatrick skin type I-VI), including tanned skin.

(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)

Miriam C. Provost

(Division Division of Ge Rest - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - and Neurological Devices.

**510(k) Number** K041959