Panels › General, Plastic Surgery › Product code OUH · Class 2
Skin Resurfacing Rf Applicator
Regulation 878.4400
0510(k)s in 12 months (5 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in OUH
| Company | 510(k)s | Recalls |
|---|---|---|
| Endymed Medical, Ltd. | 3 | 0 |
| Aesthetics Biomedical, Inc. | 0 | 1 |
| Jeisys Medical, Inc. | 1 | 0 |
| Sung Hwan E&B Co.,Ltd | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 15, 2016 | K150409 | VIVACE Electrosurgical System Sung Hwan E&B Co.,Ltd, KR | OUH |
| Jun 4, 2015 | K142833 | INTRAGen Jeisys Medical, Inc., KR | OUH |
| Mar 13, 2014 | K130501 | INTENSIF Endymed Medical, Ltd., IL | OUH |
| May 8, 2012 | K120513 | GLOW BY ENDYMED Endymed Medical, Ltd., IL | OUH |
| Feb 17, 2011 | K101510 | FRACTIONAL SKIN RESURFACING (FSR) APPLICATOR Endymed Medical, Ltd., IL | OUH |
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