Panels › General, Plastic Surgery › Product code OUP · Class 2
Powered Surgical Instrument For Improvement In The Appearance Of Cellulite
Regulation 878.4790
0510(k)s in 12 months (9 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in OUP
| Company | 510(k)s | Recalls |
|---|---|---|
| Ulthera, Inc. | 4 | 1 |
| Cabochon Aesthetics, Inc. | 2 | 0 |
| Revelle Aesthetics, Inc. | 2 | 0 |
| Nc8, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 18, 2023 | K232153 | Avéli Revelle Aesthetics, Inc. | OUP |
| Aug 5, 2022 | K221336 | Avéli Revelle Aesthetics, Inc. | OUP |
| Oct 22, 2021 | K212399 | Aveli Nc8, Inc. | OUP |
| Oct 9, 2019 | K192185 | The Cellfina System Ulthera, Inc. | OUP |
| Oct 5, 2016 | K161885 | The Cellfina System Ulthera, Inc. | OUP |
| Feb 25, 2016 | K153677 | The Cellfina System Ulthera, Inc. | OUP |
| Jul 29, 2015 | K150505 | Cellfina System Ulthera, Inc. | OUP |
| Apr 14, 2014 | K134010 | CABOCHON SYSTEM Cabochon Aesthetics, Inc. | OUP |
| Jul 12, 2013 | DEN110004 | CABOCHON SYSTEM Cabochon Aesthetics, Inc. | OUP |
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