MODIFICATION TO AURORA DS

K033586 · Syneron Medical, Ltd. · GEX · Dec 10, 2003 · General, Plastic Surgery

Device Facts

• Record ID: K033586
• Device Name: MODIFICATION TO AURORA DS
• Applicant: Syneron Medical, Ltd.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Dec 10, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Aurora DS is intended for use in dermatology for non invasive hair removal.

Device Story

Aurora DS is a non-invasive hair removal device utilizing selective thermolysis. It delivers combined optical and radiofrequency (RF) energy to target hair follicles. By optimizing spectrum, exposure duration, and energy density, the device selectively destroys hair and follicles while sparing surrounding tissues. It is intended for use in a clinical dermatology setting by trained professionals. The device output allows practitioners to perform hair removal procedures, providing a non-invasive alternative to traditional methods. This specific submission covers a modification involving an increase in light energy output.

Clinical Evidence

No clinical data provided; substantial equivalence is based on the modification of an existing cleared device.

Technological Characteristics

Device utilizes combined optical and radiofrequency (RF) energy for selective thermolysis. Modification involves increased light energy output. Class II device under 21 CFR 878.4810 and 878.4400 (Product Codes GEX, GEI).

Indications for Use

Indicated for non-invasive hair removal 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 DS (K031988)

Submission Summary (Full Text)

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## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS SYNERON MEDICAL Ltd. AURORA 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., Appolo Bld., Industrial Zone Yoqneam Illit, Israel Tel. [phone], Fax [phone]
Name of the Device: Aurora DS

| Predicate Devices: | This is a Special 510(k) for the Aurora<br>DS that was cleared under K031988. |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Description: | The Aurora DS is a device that is used<br>for non-invasive hair removal. The<br>Aurora DS treatment is based on a<br>principle of selective thermolysis.<br>According to this principle, parameters<br>of optical and RF energy (spectrum,<br>exposure duration and energy density)<br>are chosen (and optimized) to selectively<br>damage (destroy) hair and follicle<br>without damaging the surrounding<br>tissues. |

The Aurora DS is intended for use in dermatology for non invasive hair removal.

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 an increase in the light energy 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.

Arie Waller

6 November 2003

Dr. Amir Waldman Director, Regulatory affairs Syneron Medical Ltd.

Date

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 0 2003

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

Re: K033586 Trade/Device Name: Aurora DS 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: November 6, 2003 Received: November 14, 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 docs not mean that FDA has made a dctermination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencics. 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 yours,

Muriam 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

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033586 510(k) Number

Device Name Aurora DS

Indications For Use: (separate page)

The Aurora DS is indicated for non-invasive hair removal.

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

OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use_A (Per 21 CFR 801.109)

Over The Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

uriam C. Provost

(Division of General, Restorative and Neurological Devices

510(k) Number K033586