The handpiece is used as an accessory to EndyMed Pro system, which is a noninvasive device intended for use in Dermatologic and General Surgical procedures. The handpiece is indicated for…
The handpiece is used as an accessory to EndyMed Pro system, which is a noninvasive device intended for use in Dermatologic and General Surgical procedures. The handpiece is indicated for Dermatological procedures requiring ablation and resurfacing of the skin.
Who Else Makes It
Concentrated in Guangdong (1), Beijing (1). One is registered as a contract manufacturer, able to build to a specification.
Record
Regulatory record for EndyMed Pro FSR Handpiece | Listed by | Endymed Medical Ltd, Israel |
| FDA product code | OUH |
| Device type | Skin Resurfacing Rf Applicator |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4400 |
| Establishment | Manufacturer |
| 510(k) | K101510 |
| Record published | 2018-12-31 |
| Record revised | 2023-11-21 (version 4) |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Prescription | Prescription only |
| Label carries | serial number |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.