Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
OHV — Predicate Candidate Screening
30 FDA 510(k) clearances under this product code; the 50 most recent screened below.
104 daysmedian FDA review time
459 days90th percentile
30clearances 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 |
| K240687 | SofWave System | Sofwave Medical, Ltd. | 2024-05-30 | 79 | 0 |
| K233996 | Ulthera System (UC-1 Control Unit PRIME) | Ulthera, Inc. | 2024-02-22 | 66 | 0 |
| K233104 | SofWave System | Sofwave Medical, Ltd. | 2023-12-22 | 87 | 0 |
| K232455 | SofWave System | Sofwave Medical, Ltd. | 2023-12-14 | 122 | 0 |
| K230100 | SCIZER (SC1-M410) | Classys, Inc. | 2023-11-03 | 294 | 0 |
| K231628 | BeShape One™ Device | Beshape Technologies , Ltd. | 2023-09-29 | 116 | 0 |
| K231537 | SofWave System | Sofwave Medical, Ltd. | 2023-08-28 | 90 | 0 |
| K230820 | SofWave System | Sofwave Medical, Ltd. | 2023-04-18 | 25 | 0 |
| K230019 | SofWave System | Sofwave Medical, Ltd. | 2023-03-14 | 70 | 0 |
| K223237 | SofWave System | Sofwave Medical, Ltd. | 2022-12-16 | 58 | 0 |
| K211483 | SofWave System | Sofwave Medical, Ltd. | 2021-11-15 | 187 | 0 |
| K181896 | LIPOcel | Jeisys Medical, Inc. | 2019-10-18 | 459 | 0 |
| K191421 | Sofacia System | Sofwave Medical, Ltd. | 2019-09-09 | 104 | 0 |
| K180623 | Ulthera System | Ulthera, Inc. | 2018-05-04 | 56 | 0 |
| K170370 | ULTRASHAPE POWER SYSTEM | Syneron Medical, Ltd. | 2017-05-15 | 98 | 0 |
| K162163 | UltraShape System | Syneron Medical, Ltd. | 2016-11-17 | 107 | 0 |
| K161952 | UltraShape System | Syneron Medical, Ltd. | 2016-11-07 | 115 | 0 |
| K160896 | ULTRASHAPE POWER SYSTEM | Syneron Medical, Ltd. | 2016-07-08 | 99 | 0 |
| K141708 | ULTRASHAPE SYSTEM | Syneron Medical, Ltd. | 2014-10-06 | 104 | 0 |
| K134032 | ULTHERA SYSTEM | Ulthera, Inc. | 2014-06-20 | 171 | 0 |
| K133238 | CONTOUR I V3.1 SYSTEM | Syneron Medical, Ltd. | 2014-04-10 | 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 |
| K112626 | LIPSONIX(R) SYSTEM MODEL 2 | Medicis Technologies Corporation | 2011-10-20 | 41 | 0 |
| K100874 | LIPOSONIX SYSTEM, MODEL 1 P00XXXX | Medicis Technologies Corporation | 2011-08-19 | 507 | 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