OUH
5 FDA 510(k) clearances · Product code
261 daysmedian time to decision
379 days90th percentile
5clearances measured
FDA profile
- Official device name
- Skin Resurfacing Rf Applicator
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4400
- Medical specialty
- General, Plastic Surgery
- FDA definition
- Skin resurfacing
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| VIVACE Electrosurgical System (K150409) | Sung Hwan E&B Co.,Ltd | 2016-01-15 |
| INTRAGen (K142833) | Jeisys Medical, Inc. | 2015-06-04 |
| INTENSIF (K130501) | Endymed Medical, Ltd. | 2014-03-13 |
| GLOW BY ENDYMED (K120513) | Endymed Medical, Ltd. | 2012-05-08 |
| FRACTIONAL SKIN RESURFACING (FSR) APPLICATOR (K101510) | Endymed Medical, Ltd. | 2011-02-17 |
Track OUH automatically
Every clearance here is in the API, with alerts when new ones post.