AURORA DS, DS APPLICATOR

K050796 · Syneron Medical, Ltd. · GEX · Apr 12, 2005 · General, Plastic Surgery

Device Facts

• Record ID: K050796
• Device Name: AURORA DS, DS APPLICATOR
• Applicant: Syneron Medical, Ltd.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Apr 12, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Aurora DS is indicated for the removal of unwanted hair from skin types I-VI, and to effect stable long-term, or permanent, hair reduction

Device Story

Aurora DS is a dermatological device for hair removal; utilizes selective thermolysis principle; delivers combined optical and RF energy to target hair follicles; parameters (spectrum, exposure duration, energy density) optimized to damage pigmented structures while sparing surrounding tissue; operated by clinicians in dermatology settings; output consists of controlled energy pulses; modification involves change to light spectrum output; intended to provide stable long-term or permanent hair reduction.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological comparison and design modification analysis.

Technological Characteristics

Energy source: combined optical and RF energy. Principle: selective thermolysis. Form factor: DS Applicator. Intended for dermatology use. No specific materials or software architecture details provided.

Indications for Use

Indicated for removal of unwanted hair and stable long-term or permanent hair reduction in patients with skin types I-VI.

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 (K041969)

Submission Summary (Full Text)

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#### APR I 2 2005

## 510(k) SUMMARY OF SAFETY AND EFF

#### SYNERON MEDICAL Ltd. AURORA DS / DS Applicator

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., Tavor Bld., Industrial Zone Yokneam Illit, Israel Tel. [phone], Fax [phone]

Name of the Device: Aurora DS , DS Applicator

Predicate Devices: This is a Special 510(k) for the Aurora DS that was cleared under K041969.

Device Description: The Aurora DS is a device that is used for the removal of unwanted hair from skin types I-VI, and to effect stable long-term, or permanent, hair reduction. The Aurora DS 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 DS is intended for use in dermatology for the removal of unwanted hair from skin types I-VI, and to effect stable long-term, or permanent, hair reduction.

The modifications to the Aurora DS 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.

March 24 20005

Dr. Amir Waldman

Amir Walen

VP regulatory & clinical affairs Syneron Medical Ltd.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a human figure embracing a globe, which is a symbol of the department's mission to protect the health of all Americans and provide essential human services.

#### Public Health Service

APR 1 2 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Dr. Amir Waldman VP, Regulatory and Clinical Affairs Syneron Medical Ltd. Industrial Zone Yokneam Illit, 20692 P.O.B. 550, Isreal

Re: K050796

Trade/Device Name: Aurora DS, DS Applicator 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: March 24, 2005 Received: March 29, 2005

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 prexted 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/industry/support/index.html.

Sincerely yours,

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

Enclosure

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# Indications for Use

510(k) Number (if known): K050 796

Device Name: Aurora DS, DS Applicator

Indications For Use: The Aurora DS is indicated for the removal of unwanted hair from skin types I-VI, and to effect stable long-term, or permanent, hair reduction

Prescription Use _ × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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K.

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