(368 days)
Not Found
No
The summary describes a radio frequency applicator for dermatological procedures, with no mention of AI, ML, image processing, or data-driven algorithms.
No
The device is intended for dermatological procedures such as ablation, resurfacing, and treatment of facial wrinkles, which are cosmetic or aesthetic procedures rather than therapeutic in the medical sense.
No
The device is described as being used for "dermatological procedures requiring ablation and resurfacing of the skin, and for the treatment of facial wrinkles," which are therapeutic rather than diagnostic actions. Its operation involves the "delivery of bipolar radio frequency to the skin surface," further indicating a treatment function.
No
The device description explicitly lists hardware components such as a connector, cable, handpiece, and disposable tips, indicating it is a physical medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "dermatological procedures requiring ablation and resurfacing of the skin, and for the treatment of facial wrinkles." This describes a procedure performed directly on the patient's skin for therapeutic and cosmetic purposes.
- Device Description: The device delivers radio frequency energy to the skin surface via electrode-pins. This is a physical intervention on the body.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not interact with such specimens.
Therefore, the Matrix RF Applicator is a therapeutic/cosmetic device used for dermatological procedures, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
GEI
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Skin, facial
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
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.(b)
Classification. Class II.
0
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 |
|---|---|
| --------------- | --------- |