MATRIX RF APPLICATOR

K090025 · Syneron Medical, Ltd. · GEI · Jan 8, 2010 · General, Plastic Surgery

Device Facts

• Record ID: K090025
• Device Name: MATRIX RF APPLICATOR
• Applicant: Syneron Medical, Ltd.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Jan 8, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

The Matrix RF Applicator is a handpiece-based device used by clinicians for dermatological procedures. It consists of a connector, cable, handpiece, and disposable tips. The device delivers bipolar radio frequency (RF) energy to the skin surface through an array of electrode-pins. This energy delivery facilitates skin ablation and resurfacing, as well as the treatment of facial wrinkles. The device is operated by a healthcare professional in a clinical setting.

Clinical Evidence

No clinical data provided; substantial equivalence is based on the established performance characteristics and principle of operation of the predicate devices.

Technological Characteristics

The device utilizes bipolar radio frequency energy delivered via an array of electrode-pins. It is a handpiece-based system including a connector, cable, and disposable tips. It is classified as an electrosurgical cutting and coagulation device (21 CFR 878.4400).

Indications for Use

Indicated for patients requiring dermatological skin ablation, resurfacing, and treatment of facial wrinkles.

Regulatory Classification

Identification

An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.

Predicate Devices

• Matrix RF Applicator (K073572)
• Thermage ThermaCool System (K052936)
• Accent (K070004)

Submission Summary (Full Text)

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K090025

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## 510(K) Summary of Safety and Effectiveness

JAN - 8 2010

This summary of safety and effectiveness information is being submitted in accordance with ihe requirements of the SMDA 1990 and 21 CFR 807,92.

| Submitter: | Syneron Medical Ltd.,<br>Industrial Park. P.O.B. 550<br>Yokneam Illit, 20692, Israel<br>Tel. [phone] (ext. 591);<br>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>- Matrix RF Applicator, manufactured by Syneron, Ltd., and<br>subject of K073572<br>- Thermage ThermaCool System, manufactured by<br>Thermage and subject of K052936<br>- Accent, manufactured by Alma Lasers, Ltd., and subject of<br>K070004 |
| Device description: | The Matrix RF Applicator is composed of a connector, cable,<br>handpiece and disposable tips. Treatment using the Matrix RF<br>Applicator is based on delivery of bipolar radio frequency to the<br>skin surface via an array of electrode-pins. |
| Indications for Use: | The Matrix RF Applicator is intended for dermatological procedures<br>requiring ablation and resurfacing of the skin, and for the treatment<br>of facial wrinkles. |

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Conclusion:

The overall specifications, principle of operation, performance characteristics of Matrix RF Applicator device have not been changed. Therefore, the additional indication for use of the Matrix RF Applicator device should raise no new issues of safety. The device was found to be effective for the new indication, supporting the additional indication of the device for ablation and resurfacing of the skin for wrinkle treatment.

07/16/2020

Avi Hirshzon

ಿಡೀಪ

VP QA and Regulatory Affairs

Syneron Medical Ltd.

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## Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

Syneron Medical Ltd. % Mr. Avi Hirshnzon VP, QA and Regulatory Affairs Industrial Park P.O.B. 550 Yokneam Illit, 20692, Israel

JAN - 8 2010

Re: K090025

Trade/Device Name: Matrix RF Applicator Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: November 02, 2009 Received: November 06, 2009

Dear Mr. Hirshnzon:

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 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

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Page 2 – Mr. Avi Hirshnzon

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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.

Sincerely yours,

For

N. Mulla

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

Enclosure

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## Indications for Use

510(k) Number: K090025

Device Name: Matrix RF Applicator

Indications for Use:

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

| Prescription Use | X |
|-----------------------------|--------|
| (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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

| 510(k) Number | 2090025 |
|---------------|---------|
|---------------|---------|