MATRIX RF APPLICATOR

K073572 · Syneron Medical, Ltd. · GEX · Sep 17, 2008 · General, Plastic Surgery

Device Facts

• Record ID: K073572
• Device Name: MATRIX RF APPLICATOR
• Applicant: Syneron Medical, Ltd.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Sep 17, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Matrix RF Applicator is intended for dermatological procedures requiring ablation and resurfacing of the skin.

Device Story

Matrix RF Applicator is a medical device for dermatological procedures. It consists of a connector, cable, handpiece, and disposable tips. The device delivers bipolar high-frequency electrical current to the skin surface via an array of electrode-pins. This energy delivery facilitates skin ablation and resurfacing. The device is intended for use by healthcare professionals in a clinical setting. By applying controlled RF energy, the device enables skin resurfacing, which can improve skin texture and appearance.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and performance comparisons to predicate devices.

Technological Characteristics

Bipolar high-frequency electrical current delivery system. Components include connector, cable, handpiece, and disposable tips. Energy is delivered via an array of electrode-pins to the skin surface.

Indications for Use

Indicated for dermatological procedures requiring ablation and resurfacing of the skin.

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

• ThermaCool (Thermage, K052936)
• UltraPulse Encore (Lumenis, K022060)
• Lux1540 (Palomar, K061652)
• Lovely/Harmony (MSq, currently Alma Lasers, K042000)
• Portrait PSR3 (Rhytec, K072394)

Submission Summary (Full Text)

{0}------------------------------------------------

## Ko73572 SEP 1 7 2008 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

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., Industrial Park, P.O.B. 550<br>Yokneam Illit, 20692, Israel<br>Tel. [phone] (ext. 591); Fax [phone] |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Name of the Device: | Matrix RF Applicator |
| Predicate Devices: | This is a 510(k) submission for the Matrix RF Applicator that is<br>substantially equivalent to the following cleared devices:<br>ThermaCool (Thermage, K052936); UltraPulse Encore<br>(Lumenis, K022060); Lux1540 (Palomar, K061652);<br>Lovely/Harmony (MSq, currently Alma Lasers, K042000);<br>Portrait PSR3 (Rhytec, K072394). |
| Device Description: | The Matrix RF Applicator is composed of a connector, cable, |

- handpiece and disposable tips. Treatment using the Matrix RF Applicator is based on delivery of bipolar high frequency electrical current to the skin surface via an array of electrode-pins.
- Indications for Use: The Matrix RF Applicator is intended for dermatological procedures requiring ablation and resurfacing of the skin.
- The overall performance characteristics of the Matrix RF Conclusion: Applicator, including pulse parameters and depth of impact, are substantially equivalent to those of the predicate devices. Therefore, the Matrix RF Applicator should raise no new issues of safety and effectiveness.

September 8, 2008

Sam I,

Yoni Iget, Ph.D. Director of Clinical & Regulatory Affairs Syneron Medical Ltd.

Date

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" arranged around the perimeter. Inside the circle is a stylized eagle emblem with three curved lines representing the eagle's body and wings.

SEP 1 7 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Syneron Medical Ltd. % Yoni Iger, Ph.D. Direcotr, Clinical and Regulatory Affairs Sultam Industrial Park P.O. Box 550, Yokneam Illit 20692, Israel

Re: K073572

Trade/Device Name: Matrix RF 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: September 8, 2008 Received: September 11, 2008

Dear Dr. Iger:

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. Iisting 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

{2}------------------------------------------------

Page 2 - Yoni Iger, Ph.D.

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.

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 Center for Devices and Radiological Health's (CDRH's) Office of Comrliary, pro [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Pestmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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 a its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Mark M Millican

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

## Indications for Use

510(k) Number: K073572

Device Name: Matrix RF Applicator

Indications for Use:

The Matrix RF Applicator is intended for dermatological procedures requiring ablation and resurfacing of the skin.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Divisio Division of General, Restorative, and Neurological Devices

**510(k) Number** K073572