Skin Resurfacing Rf Applicator
FDA product code OUH · Class II (moderate risk) · 21 CFR 878.4400 · General, Plastic Surgery
Skin resurfacing
5510(k) clearances
0PMA approvals
1recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K150409 | VIVACE Electrosurgical SystemOUH · Traditional | Sung Hwan E&B Co.,Ltd | 01/15/2016SE |
| K142833 | INTRAGenOUH · Traditional | Jeisys Medical, Inc. | 06/04/2015SE |
| K130501 | IntensifOUH · Traditional | Endymed Medical, Ltd. | 03/13/2014SE |
| K120513 | Glow by EndymedOUH · Traditional | Endymed Medical, Ltd. | 05/08/2012SE |
| K101510 | Fractional Skin Resurfacing (FSR) ApplicatorOUH · Traditional | Endymed Medical, Ltd. | 02/17/2011SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0444-2021 Class II | SUNG HWAN E&B VIVACE Shenb Innovation of Beauty Technologyt - Product Usage: intended…A high frequency output (2 MHz) has not been cleared for distribution in the U.S. | Aesthetics Biomedical, Inc. | 03/13/2020Terminated |