(261 days)
K08346
No
The summary describes a device that uses bipolar RF energy for skin resurfacing and ablation. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in the provided text.
Yes
The device is intended for "dermatological procedures requiring ablation and resurfacing of the skin," which are therapeutic applications. Additionally, performance studies evaluate its "safety and efficacy" as an "effective, safe device for skin resurfacing."
No
The device is described as being for "dermatological procedures requiring ablation and resurfacing of the skin," which are treatment procedures, not diagnostic ones.
No
The device description explicitly states it is a "treatment handpiece" and "Applicator tip" that emits "bipolar RF energy," indicating it is a hardware component, 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." This is a therapeutic procedure performed directly on the patient's skin.
- Device Description: The device emits bipolar RF energy to create micro-ablation points on the skin. This is a physical interaction with the body, not a test performed on a sample taken from the body.
- Lack of IVD Characteristics: There is no mention of analyzing samples (like blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. The device's function is to treat the skin directly.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Fractional Skin Resurfacing (FSR) Applicator is intended for dermatological procedures requiring ablation and resurfacing of the skin
Product codes
OUH
Device Description
EndyMed's Fractional Skin Resurfacing (FSR) Applicator is a treatment handpiece to be attached to the FDA cleared EndyMed Imagine TC Skin Treatment System (K08346). The FSR Applicator tip emits bipolar RF energy that flows between electrodes to create micro-ablation points on the skin, forming superficial ablation with a volumetric non ablative heating effect in the dermis. :
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
skin
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
The safety and efficacy of the Fractional Skin Resurfacing (FSR) Applicator was evaluated in a performance testing.
The results of this testing clearly indicate that the Fractional Skin Resurfacing (FSR) Applicator offers a non-invasive, effective, safe device for skin resurfacing.
The performance tests demonstrate that the Fractional Skin Resurfacing (FSR) Applicator is as safe, as effective, and performs at least as safely and effectively as the legally marketed device.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
FEB 17 2011
510(K) SUMMARY
Fractional Skin Resurfacing (FSR) Applicator 510(k) Number K101510
| Applicant's Name: | EndyMed Ltd |
|---|---|
| 7 Bareket Street, | |
| North Industrial Park, | |
| Caesarea, 30889 Israel | |
| Tel: (972)4-630-9100 | |
| Fax: (972)4-630-9101 | |
| Contact Person: | Yoram Levy, Qsite |
| 31 Haavoda Street | |
| Binyamina, Israel 30500 | |
| Tel (972)4-638-8837; Fax (972)4-638-0510 | |
| Yoram@qsitemed.com | |
| Trade Name: | Fractional Skin Resurfacing (FSR) Applicator |
| Preparation Date: | April 29, 2010 |
| Classification: | Name: Electrosurgical, cutting & coagulation device |
| & accessories | |
| Product Code: OUH | |
| Regulation No: 21 CFR 878.4400 | |
| Class: II | |
| Panel: General and Plastic Surgery |
Device Description:
EndyMed's Fractional Skin Resurfacing (FSR) Applicator is a treatment handpiece to be attached to the FDA cleared EndyMed Imagine TC Skin Treatment System (K08346). The FSR Applicator tip emits bipolar RF energy that flows between electrodes to create micro-ablation points on the skin, forming superficial ablation with a volumetric non ablative heating effect in the dermis. :
Intended Use Statement:
The Fractional Skin Resurfacing (FSR) Applicator is intended for dermatological procedures requiring ablation and resurfacing of the skin
1
Predicate Devices: Substantial equivalence to the following predicate devices is claimed:
| Device Name | 510k No | Date of Clearance |
|---|---|---|
| Syneron Matrix RF | ||
| Applicator | K073572 | Sep 17, 2008 |
| EndyMed Imagine TC Skin | ||
| Treatment System | K083461 | Jul 24, 2009 |
Performance Standards:
Fractional Skin Resurfacing (FSR) Applicator complies with
- EN 60601-1 (Medical Electrical Equipment-Part 1: General . Requirements for Safety-1. Collateral Standard: Safety Requirements for Medical Electrical Systems).
- IEC 60601-1-2 (Electromagnetic compatibility (EMC) .
- ANSI AAMI 60601-2-2 for safety of high frequency surgical ● equipment.
A detailed description appears in Section 14.
Summary of Clinical performance data:
The safety and efficacy of the Fractional Skin Resurfacing (FSR) Applicator was evaluated in a performance testing.
The results of this testing clearly indicate that the Fractional Skin Resurfacing (FSR) Applicator offers a non-invasive, effective, safe device for skin resurfacing.
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Image /page/2/Picture/0 description: The image shows the logo for EndyMed, a company specializing in 3DEEP technology. The logo features the company name in a bold, sans-serif font, with the letters slightly spaced apart. To the left of the name is a pattern of dots arranged in a grid-like formation. Below the company name, in a smaller font, is the tagline "THE 3DEEP COMPANY".
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Conclusion
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The performance tests demonstrate that the Fractional Skin Resurfacing (FSR) Applicator is as safe, as effective, and performs at least as safely and effectively as the legally marketed device.
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Image /page/3/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" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three stylized lines above a wavy base.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
EndyMed Medical, Ltd. % Osite Yoram Levy 31 Haavoda Street Binyamina 30500 Isracl
FEB 17 200
Re: K101510
Trade/Device Name: Fractional Skin Resurfacing (FSR) Applicator Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: OUH Dated: January 21, 2011 Received: January 31, 2011
Dear Yoram Levy:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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
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Page 2 - Yoram Levy
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
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/MedicalDevices/Safety/ReportaProblem/default.htm 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/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Kiz B. Rhr
fer
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
k/0/5/0
Image /page/5/Picture/1 description: The image shows the logo for EndyMed, a company that specializes in 3DEEP technology. The logo features a grid of dots on the left, followed by the company name in a bold, sans-serif font. Below the company name is the tagline "THE 3DEEP COMPANY" in a smaller font. The logo is simple and modern, and it effectively communicates the company's focus on advanced technology.
INDICATIONS FOR USE STATEMENT
510(k) Number (if known):
Device Name:
Fractional Skin Resurfacing (FSR) Applicator
Indications for Use:
The Fractional Skin Resurfacing (FSR) Applicator is intended for dermatological procedures requiring ablation and resurfacing of the skin
Use X Prescription (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 General, Restorative and Neurological Devices 510(k) Number
Nathalie Olson Forman
Division Sign Off
Division Sign-Off Division of Surgical, Orthopedic, and Restorative Devices
. 510(k) Number. K101510
EndyMed Fractional Skin Resurfacing (FSR) Applicator - 510k Notification