OUP
9 FDA 510(k) clearances · Product code
86 daysmedian time to decision
620 days90th percentile
9clearances measured
FDA profile
- Official device name
- Powered Surgical Instrument For Improvement In The Appearance Of Cellulite
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4790
- Medical specialty
- General, Plastic Surgery
- FDA definition
- Used for controlled release of subcutaneous tissue for improvement in the appearance of cellulite.
- Adverse events (MAUDE)
- 2019: 16 · 2022: 15
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Avéli (K232153) | Revelle Aesthetics, Inc. | 2023-08-18 |
| Avéli (K221336) | Revelle Aesthetics, Inc. | 2022-08-05 |
| Aveli (K212399) | Nc8, Inc. | 2021-10-22 |
| The Cellfina System (K192185) | Ulthera, Inc. | 2019-10-09 |
| The Cellfina System (K161885) | Ulthera, Inc. | 2016-10-05 |
| The Cellfina System (K153677) | Ulthera, Inc. | 2016-02-25 |
| Cellfina System (K150505) | Ulthera, Inc. | 2015-07-29 |
| CABOCHON SYSTEM (K134010) | Cabochon Aesthetics, Inc. | 2014-04-14 |
| CABOCHON SYSTEM (DEN110004) | Cabochon Aesthetics, Inc. | 2013-07-12 |
Track OUP automatically
Every clearance here is in the API, with alerts when new ones post.