AURORA SR AND SRA APPLICATOR

K050452 · Syneron Medical, Ltd. · GEX · Mar 9, 2005 · General, Plastic Surgery

Device Facts

• Record ID: K050452
• Device Name: AURORA SR AND SRA APPLICATOR
• Applicant: Syneron Medical, Ltd.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Mar 9, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Aurora SR is intended for use in dermatology for superficial benign vascular and pigmented lesion treatment.

Device Story

The Aurora SR is a dermatological device utilizing selective thermolysis to treat superficial benign vascular and pigmented lesions. It delivers combined optical and radiofrequency (RF) energy to target lesions while sparing surrounding tissue. Parameters including spectrum, exposure duration, and energy density are optimized for specific lesion types. The device is operated by clinicians in a dermatological setting. The output is delivered via an applicator to the skin surface, allowing the practitioner to selectively damage vascular or pigmented structures. This process aims to improve the appearance of skin lesions. The device is a modification of a previously cleared system, specifically involving a change in the light spectrum output.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

The device utilizes selective thermolysis via combined optical and radiofrequency (RF) energy. It consists of a main unit and an SR applicator. The primary technological modification is an adjustment to the light spectrum output. The device is classified as a laser surgical instrument and electrosurgical cutting/coagulation device (21 CFR 878.4400).

Indications for Use

Indicated for the treatment of superficial benign vascular and pigmented 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

• Aurora SR (K031993)

Submission Summary (Full Text)

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K050452

## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

## SYNERON MEDICAL Ltd. AURORA SR / SR Applicator

This summary of safety and effectiveness information is being submitted in This Summary of Sareey and vents of the SMDA 1990 and 21 CFR 807.92.

Syneron Medical Ltd., Tavor Bld., Submitter: Industrial Zone Yoqneam Illit, Israel Tel. [phone], Fax [phone]

Name of the Device: Aurora SR , SR Applicator

This is a Special 510(k) for the Aurora SR that was cleared Predicate Devices: under K031993.

- Device Description: The Aurora SR is a device that is used for superficial benign vascular and pigmented lesion treatment. The Aurora SR treatment is based on a principle of selective thermolysis. According to this principle, parameters of optical and RF energy (spectrum, exposure duration and energy density) are chosen (and optimized) to selectively damage (destroy) vascular and pigmented lesions without damaging the surrounding tissues.
The Aurora SR is intended for use in dermatology for superficial benign vascular and pigmented lesion treatment.

The modifications to the Aurora SR do not affect the intended use or alter the fundamental scientific technology of the device. The only device modification is changing the light spectrum output. There are no labeling changes that affect the intended use of the device. The device modifications raise no new issues of safety or effectiveness.

Air Waldron

February 17 2005

Date

Dr. Amir Waldman VP Regulation and 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 consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 9 - 2005

Dr. Amir Waldman Dr. Allin Want, Regulation and Clinical Affairs Syneron Medical Ltd. P.O. Box 550 Industrial Zonc Yokneam Illit, 20692 Israel

Re: K050452

K030452
Trade/Device Name: Aurora SR, SR Applicator Trade/Device Name: Traine: Treater 21 CFR 878.4400 Regulation Name: Laser surgical instrument for use in general and Laser surgery and in dermatology; Electrosurgical cutting and coagulation device and accessories Regulatory Class: II

Product Code: GEX and GEI Dated: February 17, 2005 Received: February 22, 2005

Dear Dr. Waldman:

We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 910(x) premainted institution of the indications
referenced above and have determined the device is substantially interstate referenced above and nave decimined the devices marketed in interstate for use stated in the encrosule) to regary maneted prouter of the Medical Tevice Ameralments, or to commerce prior to May 28, 1776, the enacertance with the provisions of the Federal Food, Drug. devices that have been recordance with approval of a premarket approval applications of the Act. The and Cosment Act (Act) that do not require approvate of the general controls provisions of the Act. The
You may, therefore, market the device, subject to the generation, l You may, merelore, market the device, bacycer to the generate for annual registration, listing of general controls provisions of the Frec mercial required in the supering misbranding and adultcration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA). in If your device is classified (see above) the existing major regulations affecting your device can
may be subject to such additional controls. Existing major and condition may be subject to such additional controller Entisting may - - - - - - - - - - - - - - - - - - - - - - 800 to 898 - 1 - - - - - - - - - - - - - - - - - - - - - - - - - - - be found in the Code of Pederal Regarding your device in the Federal Register.

Please be advised that FDA`s issuance of a substantial equivalonee determination does not mean Please be advised that FDA S Issualice of a substance complies with other requirements of the Act
that FDA has made a determination that your device complies - You must that FDA has made a delerimiation that your de ros by other Federal agencies. You must or any Federal statutes and regulations daminding, but not limited to: registration and listing ( 2 ) comply with all the Act s requirements, mending on the requirements as set
CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice the electronic CFR Part 807), labeling (21 CFR Part 807), government 820); and if applicable. the electronic
forth in the quality systems (QS) regulation (21 CFR 1000 1050 forth in the quality systems (QS) regulation (Sections 531-542 of the Act): 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000

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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) This letter will anow you to begin maneting of substantial equivalence of your device to a legally premaired nother in the PDA miaing of basification 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 for your as 110 76-0115. Also, please note the regulation entitled, Colliact the Office of Compliance an (21 t ritification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

2

· Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices ()ffice of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number - - - - - - -K057452

Device Name___________________________________________________________________________________________________________________________________________________________________

Indications For Use: (separate page)

The Aurora SR is indicated for superficial benign vascular and pigmented lesion treatment.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use V (Per 21 CFR 801.109)

OR

Over The Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

**(Division Sign-Off)**

Division of General, Restorative, and Neurological Devices

510(k) Number_11050452