← Product Code [GEI](/submissions/SU/subpart-e%E2%80%94surgical-devices/GEI) · K090025 # MATRIX RF APPLICATOR (K090025) _Syneron Medical, Ltd. · GEI · Jan 8, 2010 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEI/K090025 ## Device Facts - **Applicant:** Syneron Medical, Ltd. - **Product Code:** [GEI](/submissions/SU/subpart-e%E2%80%94surgical-devices/GEI.md) - **Decision Date:** Jan 8, 2010 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 878.4400 - **Device Class:** Class 2 - **Review Panel:** General, Plastic Surgery - **Attributes:** Therapeutic ## 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. ## 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). ## Regulatory 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](/device/K073572.md)) - Thermage ThermaCool System ([K052936](/device/K052936.md)) - Accent ([K070004](/device/K070004.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ K090025 Image /page/0/Picture/1 description: The image shows the word "Syneron" in a stylized font. The word is written in a slightly slanted, cursive style. Below the word "Syneron" are some indiscernible markings. 元 前 官 河北公 ## 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.,
Industrial Park. P.O.B. 550
Yokneam Illit, 20692, Israel
Tel. +972-73-244-2200 (ext. 591);
Fax +972-73-244-2202 | |----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Name of the Device: | Matrix RF Applicator | | Predicate Devices: | This is a 510(k) submission for the Matrix RF Applicator that is
substantially equivalent to the following cleared devices.
- Matrix RF Applicator, manufactured by Syneron, Ltd., and
subject of K073572
- Thermage ThermaCool System, manufactured by
Thermage and subject of K052936
- Accent, manufactured by Alma Lasers, Ltd., and subject of
K070004 | | 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 radio frequency 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, and for the treatment
of facial wrinkles. | 5-1 {1}------------------------------------------------ Image /page/1/Picture/0 description: The image shows the word "Syneron" in a stylized font. The letters are slightly distorted, giving the word a unique appearance. The image is simple and focuses on the company name. 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. {2}------------------------------------------------ Image /page/2/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 graphic of three human profiles facing right, resembling a bird in flight. ## 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 {3}------------------------------------------------ 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 (800) 638-2041 or (301) 796-7100 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 {4}------------------------------------------------ ## 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 | |---------------|---------| |---------------|---------| --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEI/K090025](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEI/K090025) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com