The Cellfina System
FDA 510(k) clearance K161885 · decided 2016-10-05
Clearance details
- K-number
- K161885
- Device name
- The Cellfina System
- Applicant
- Ulthera, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2016-07-11
- Decision date
- 2016-10-05
- Days to decision
- 86 days
- Clearance type
- Traditional
- Product code
- OUP
- Device class
- 2
- Regulation number
- 878.4790
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Mesa, AZ, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| 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 (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 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Cellfina Prep Pack, Part No. CP1 recall (Z-0749-2017) | Ulthera Inc | 2016-12-13 |