FDA Product Code
FDA Product Code OUP — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General, Plastic Surgery
- 21 CFR Citation
- 878.4790
510(k) Clearances — 9 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K232153 | Avéli | Revelle Aesthetics, Inc. | 2023-08-18 | Special | PDF ↗ |
| K221336 | Avéli | Revelle Aesthetics, Inc. | 2022-08-05 | Traditional | PDF ↗ |
| K212399 | Aveli | Nc8, Inc. | 2021-10-22 | Traditional | PDF ↗ |
| K192185 | The Cellfina System | Ulthera, Inc. | 2019-10-09 | Traditional | PDF ↗ |
| K161885 | The Cellfina System | Ulthera, Inc. | 2016-10-05 | Traditional | PDF ↗ |
| K153677 | The Cellfina System | Ulthera, Inc. | 2016-02-25 | Special | PDF ↗ |
| K150505 | Cellfina System | Ulthera, Inc. | 2015-07-29 | Traditional | PDF ↗ |
| K134010 | CABOCHON SYSTEM | Cabochon Aesthetics, Inc. | 2014-04-14 | Traditional | PDF ↗ |
| DEN110004 | CABOCHON SYSTEM | Cabochon Aesthetics, Inc. | 2013-07-12 | Post-NSE | — |
Product code OUP · Class II · General, Plastic Surgery. Data: openFDA.