Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Ulthera, Inc. — Predicate Candidate Screening
14 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
89 daysmedian FDA review time
171 days90th percentile
14clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K260618 | Ulthera® System | Ulthera, Inc. | 2026-05-21 | 85 | 0 |
| K250418 | Ulthera System (UC-1 Control Unit PRIME Model 2.1) | Ulthera, Inc. | 2025-05-13 | 89 | 0 |
| K243035 | Ulthera® System | Ulthera, Inc. | 2025-02-24 | 150 | 0 |
| K233996 | Ulthera System (UC-1 Control Unit PRIME) | Ulthera, Inc. | 2024-02-22 | 66 | 0 |
| K192185 | The Cellfina System | Ulthera, Inc. | 2019-10-09 | 58 | 0 |
| K180623 | Ulthera System | Ulthera, Inc. | 2018-05-04 | 56 | 0 |
| K161885 | The Cellfina System | Ulthera, Inc. | 2016-10-05 | 86 | 1 |
| K153677 | The Cellfina System | Ulthera, Inc. | 2016-02-25 | 66 | 0 |
| K150505 | Cellfina System | Ulthera, Inc. | 2015-07-29 | 154 | 0 |
| K134032 | ULTHERA SYSTEM | Ulthera, Inc. | 2014-06-20 | 171 | 0 |
| K132028 | ULTHERA SYSTEM | Ulthera, Inc. | 2013-12-11 | 163 | 0 |
| K121700 | ULTHERA SYSTEM | Ulthera, Inc. | 2012-10-02 | 117 | 0 |
| K122528 | ULTHERA SYSTEM | Ulthera, Inc. | 2012-08-28 | 8 | 0 |
| DEN080006 | ULTHERA SYSTEM, MODEL 8850-0001 | Ulthera, Inc. | 2009-09-11 | 518 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda