FDA 510(k) Applications Submitted by ULTHERA, INC.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K134032 |
12/31/2013 |
ULTHERA SYSTEM |
ULTHERA, INC. |
| K233996 |
12/18/2023 |
Ulthera System (UC-1 Control Unit PRIME) |
Ulthera, Inc. |
| DEN080006 |
04/11/2008 |
ULTHERA SYSTEM, MODEL 8850-0001 |
ULTHERA, INC. |
| K243035 |
09/27/2024 |
Ulthera« System |
Ulthera, Inc. |
| K150505 |
02/25/2015 |
Cellfina System |
ULTHERA, INC. |
| K121700 |
06/07/2012 |
ULTHERA SYSTEM |
ULTHERA, INC. |
| K132028 |
07/01/2013 |
ULTHERA SYSTEM |
ULTHERA, INC. |
| K161885 |
07/11/2016 |
The Cellfina System |
ULTHERA, INC. |
| K122528 |
08/20/2012 |
ULTHERA SYSTEM |
ULTHERA, INC. |
| K153677 |
12/21/2015 |
The Cellfina System |
ULTHERA, INC. |
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