FDA Product Code
FDA Product Code OUH — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General, Plastic Surgery
- 21 CFR Citation
- 878.4400
510(k) Clearances — 5 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K150409 | VIVACE Electrosurgical System | Sung Hwan E&B Co.,Ltd | 2016-01-15 | Traditional | PDF ↗ |
| K142833 | INTRAGen | Jeisys Medical, Inc. | 2015-06-04 | Traditional | PDF ↗ |
| K130501 | INTENSIF | Endymed Medical, Ltd. | 2014-03-13 | Traditional | PDF ↗ |
| K120513 | GLOW BY ENDYMED | Endymed Medical, Ltd. | 2012-05-08 | Traditional | PDF ↗ |
| K101510 | FRACTIONAL SKIN RESURFACING (FSR) APPLICATOR | Endymed Medical, Ltd. | 2011-02-17 | Traditional | PDF ↗ |
Product code OUH · Class II · General, Plastic Surgery. Data: openFDA.