Company · US
Ulthera, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2009 to 2026. Name variants (Inc, Corp, punctuation) are merged.
14510(k) clearances (1 in 12 months)
1recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 21, 2026 | K260618 | Ulthera® System Ulthera, Inc. | OHV |
| May 13, 2025 | K250418 | Ulthera System (UC-1 Control Unit PRIME Model 2.1) Ulthera, Inc. | OHV |
| Feb 24, 2025 | K243035 | Ulthera® System Ulthera, Inc. | OHV |
| Feb 22, 2024 | K233996 | Ulthera System (UC-1 Control Unit PRIME) Ulthera, Inc. | OHV |
| Oct 9, 2019 | K192185 | The Cellfina System Ulthera, Inc. | OUP |
| May 4, 2018 | K180623 | Ulthera System Ulthera, Inc. | OHV |
| 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 |
| Jun 20, 2014 | K134032 | ULTHERA SYSTEM Ulthera, Inc. | OHV |
| Dec 11, 2013 | K132028 | ULTHERA SYSTEM Ulthera, Inc. | OHV |
| Oct 2, 2012 | K121700 | ULTHERA SYSTEM Ulthera, Inc. | OHV |
| Aug 28, 2012 | K122528 | ULTHERA SYSTEM Ulthera, Inc. | OHV |
| Sep 11, 2009 | DEN080006 | ULTHERA SYSTEM, MODEL 8850-0001 Ulthera, Inc. | OHV |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 13, 2016 | Ulthera Inc Cellfina Prep Pack, Part No. CP1 Terminated |
OUP | K161885 |