AC APPLICATOR, AURORA AC

K032514 · Syneron Medical, Ltd. · GEX · Jan 27, 2004 · General, Plastic Surgery

Device Facts

• Record ID: K032514
• Device Name: AC APPLICATOR, AURORA AC
• Applicant: Syneron Medical, Ltd.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Jan 27, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The AC applicator indicated for the treatment of moderate inflammatory acne vulgaries.

Device Story

AC applicator treats moderate inflammatory acne vulgaris. Device utilizes principle of selective electromagnetic thermolysis combined with photochemical reaction. Inputs consist of optical and RF energy parameters (spectrum, exposure duration, energy density). Device transforms these inputs to selectively damage acne bacteria and sebaceous glands while sparing surrounding tissue. Output is therapeutic energy delivery to skin. Used in clinical settings by healthcare professionals. Output allows clinicians to perform targeted dermatological treatment, potentially reducing acne inflammation and improving patient condition.

Clinical Evidence

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

Technological Characteristics

Device utilizes optical and RF energy for selective thermolysis and photochemical reaction. Parameters include adjustable spectrum, exposure duration, and energy density. Form factor is an applicator for dermatological use. No specific materials or software architecture details provided.

Indications for Use

Indicated for the treatment of moderate inflammatory acne vulgaris.

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)
• ClearLight phototherapy device (K013623)
• Omnilux Blue (K030883)
• Smoothbeam laser system (K014128)

Submission Summary (Full Text)

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## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS SYNERON MEDICAL Ltd. AC 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.

- Syneron Medical Ltd., Sultam Industrial park, P.O.B. 550, Submitter: Yokneam Elite 20692, Israel. Tel. [phone] ext. 7604, Fax [phone]
Name of the Device: AC applicator

- AC applicator is substantially equivalent to a combination of Predicate Devices: the following devices: Aurora SR, manufactured by Syneron Medical Ltd. and subject of K031993. ClearLight phototherapy device, manufactured by CureLight and subject of K013623. Omnilux Blue, manufactured by Photo Therapeutics limited and subject of K030883. Smoothbeam laser system, manufactured by Candela Corp. and subject of K014128.
- Device Description: The AC applicator is a device that is used for the treatment of moderate inflammatory acne vulgaries. The AC applicator treatment is based on the principle of selective (electromagnetic) thermolysis combined with photochemical reaction of the acne bacteria. According to this principle, parameters of optical and RF energy (spectrum, exposure duration and energy density) are chosen and optimized to selectively damage acne bacteria and the sebaceous glands without damaging the surrounding tissues.

The AC applicator is intended for the treatment of moderate inflammatory acne vulgaries.

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

August 12, 2003

Amir Walden

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

Date

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 7 2004

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

Re: K032514

Trade/Device Name: AC Applicator, Aurora AC 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 Codes: GEX, GEI Dated: November 13, 2003 Received: November 17, 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 (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

Sincercly yours,

Miriam C. Provost

fo' 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)_ K 032514

Device Name AC applicator.

Indications For Use:

The AC applicator indicated for the treatment of moderate inflammatory acne vulgaries.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use J (Per 21 CFR 801.109)

Over The Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

Miriam C. Provost

OR