Ulthera, Inc.
FDA 510(k) & PMA Approved Devices — 8 products
Total Devices8
Categories2
Latest FDA decision2026-05-21
| Type | Number | Device Name | Code | Date | Actions |
|---|---|---|---|---|---|
| 510(k) | K260618 | Ulthera® System | OHV | 2026-05-21 | View |
| 510(k) | K250418 | Ulthera System (UC-1 Control Unit PRIME Model 2.1) | OHV | 2025-05-13 | View |
| 510(k) | K243035 | Ulthera® System | OHV | 2025-02-24 | View |
| 510(k) | K233996 | Ulthera System (UC-1 Control Unit PRIME) | OHV | 2024-02-22 | View |
| 510(k) | K192185 | The Cellfina System | OUP | 2019-10-09 | View |
| 510(k) | K180623 | Ulthera System | OHV | 2018-05-04 | View |
| 510(k) | K161885 | The Cellfina System | OUP | 2016-10-05 | View |
| 510(k) | K153677 | The Cellfina System | OUP | 2016-02-25 | View |
No matching devices.