AURORA DS

K041969 · Syneron Medical, Ltd. · GEX · Oct 19, 2004 · General, Plastic Surgery

Device Facts

• Record ID: K041969
• Device Name: AURORA DS
• Applicant: Syneron Medical, Ltd.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Oct 19, 2004
• Decision: SESE
• Submission Type: Traditional
• 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

The Aurora DS is a light-powered surgical instrument used for hair removal. 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 tissues. It is intended for professional use in clinical settings. The device output allows clinicians to perform hair reduction procedures, potentially providing patients with stable long-term or permanent hair removal.

Clinical Evidence

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

Technological Characteristics

Light-powered surgical instrument; utilizes selective electromagnetic thermolysis via combined optical and radiofrequency (RF) energy. Designed for skin types I-VI. Technical specifications include adjustable spectrum, exposure duration, and energy density parameters.

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 (K033586)
• Palomar StarLux (K033549)
• Lovely system (K033946)

Submission Summary (Full Text)

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K 041969

## OCT 1 9 2004

## 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., Sultam Industrial park, P.O.B. 550<br>Yokneam Elite 20692, Israel.<br>Tel. [phone] ext. 352, Fax [phone] |
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Name of the Device: Aurora DS

- The Aurora DS is substantially equivalent to a combination of 3 Predicate Devices: light powered surgical instruments (21 CFR 878.4810, procode GEX): Aurora DS, manufactured by Syneron Medical Ltd. and subject of K033586. Palomar StarLux, manufactured by Palomar medical products inc. and subject of K033549. Lovely system, manufactured by Msq Ltd. and subject of K033946
- Device Description: The Aurora DS is a device indicated for the removal of unwanted hair from skin types I-VI, and to effect stable longterm, or permanent, hair reduction. The Aurora DS 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 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.

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

217107

Total column

Date

Dr. Amir Waldman, Director regulatory 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 & Human Services. The logo features a stylized depiction of an eagle with three stripes forming its body and wings. The eagle is positioned to the right of a circular text element that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 9 2004

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

Re: K041969

Trade/Device Name: Aurora DS 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, GEI Dated: July 19, 2004 Received: July 22, 2004

Dear Dr.Waldman:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your Section 310(x) premium is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the cheroours) to regars actment date of the Medical Device Amendments, or to commerce prices that have been reclassified in accordance with the provisions of the Federal Food, Drug, de rices mat have been recitablicat require approval of a premarket approval application (PMA). and Costietic rece (1101) that the nevice, subject to the general controls provisions of the Act. The 1 ou may, mercrore, market the Act include requirements for annual registration, listing of general controls proficition gractice, 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 be subject to sacer additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Ood neements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean i Teast be advisod that I Dr Crisean that your device complies with other requirements of the Act that I DA has made a determinations administered by other Federal agencies. You must or any I cueral surated and registments, 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 (21 CFR Part 820); and if applicable, the electronic form in the quinn 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) I his letter will anow you to begin manceing your avvee of your device of your device to a legally premarket notheation. The PDA miding of backanced volume 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 ac now on 5. Also, please note the regulation entitled,
contact the Office of Compliance at [phone]. Also, please note the regu collact the Office of Complanes at (21 to 7 to 10 may of any 807.97). You may obtain "Misolallung by releveloc to premanters within the Act from the Division of Small other general information on your response 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

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() ( 510(k) Number (if known)

Device Name

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.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use سا (Per 21 CFR 801.109) OR

Over The Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

Miriam C. Provost

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

**510(k) Number** Ko 41969