POLRIS LV

K030186 · Syneron Medical, Ltd. · GEX · Apr 14, 2003 · General, Plastic Surgery

Device Facts

• Record ID: K030186
• Device Name: POLRIS LV
• Applicant: Syneron Medical, Ltd.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Apr 14, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Polaris LV is intended for use in dermatology for treatment of vascular lesions.

Device Story

Polaris LV is a dermatological device for treating vascular lesions. 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 vascular lesions while sparing surrounding tissue. It is intended for clinical use by healthcare professionals. The device output allows practitioners to target specific vascular structures, facilitating lesion treatment and potentially improving patient outcomes.

Clinical Evidence

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

Technological Characteristics

The device utilizes a combination of optical and radiofrequency (RF) energy to perform selective electromagnetic thermolysis. It is designed for dermatological applications. Specific materials, dimensions, and software details are not provided.

Indications for Use

Indicated for the treatment of vascular lesions 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 DS (K024064)
• PhotoDerm Nd:YAG Accessory (K980537)
• SLP 1000 (K013028)
• Dornier Medilas D SkinPulse Laser (K020339)

Submission Summary (Full Text)

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APR 1 4 2003

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

## Medical Ltd

## Attachment 2 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS SYNERON MEDICAL Ltd. POLARIS LV

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] |
|------------|-------------------------------------------------------------------------------------------------------------------------------------------------|
|------------|-------------------------------------------------------------------------------------------------------------------------------------------------|

## Name of the Device: Polaris LV

- Predicate Devices: The Polaris LV is substantially equivalent to a combination of the following devices: the Polaris DS, manufactured by Syneron Medical Ltd. and subject of K024064; the PhotoDerm Nd:YAG Accessory, manufactured by ESC Medical Ltd., and subject of K980537; the SLP 1000, manufactured by Palomar Medical Technologies Inc., and subiect of K013028: the Dornier Medilas D SkinPulse Laser, manufactured by DornierMedTech, and subject of K020339.
- Device Description: The Polaris LV is a device that is used for treatment of vascular lesions. The Polaris LV 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 vascular lesions without damaging the surrounding tissues.

The Polaris LV is intended for use in dermatology for treatment of vascular lesions.

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

12, FEB 2023

Amin WALDMAN

Date

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

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APR 1 4 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K030186 Trade/Device Name: Polaris LV Regulation Number: 21 CFR 878.4810 Regulation Names: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Codes: GEX Dated: January 17, 2003 Received: January 21, 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 (OS) 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 - Amir Waldman, M.D.

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]. Additionally, for questions on the promotion and advertising of your device, 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 may be obtained 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,

b Mahn N Millerson

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)_Ko36 | J

Device Name___ Polaris LV.

Indications For Use:

The Polaris LV is indicated for treatment of vascular lesions.

(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)

for Mark N Millhum
(Division Sign-Off)

and IV

510(k) Number

KOSOI