FDA Product Code
FDA Product Code OHV — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General, Plastic Surgery
- 21 CFR Citation
- 878.4590
510(k) Clearances — 30 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K260618 | Ulthera® System | Ulthera, Inc. | 2026-05-21 | Traditional | PDF ↗ |
| K250418 | Ulthera System (UC-1 Control Unit PRIME Model 2.1) | Ulthera, Inc. | 2025-05-13 | Traditional | PDF ↗ |
| K243035 | Ulthera® System | Ulthera, Inc. | 2025-02-24 | Traditional | PDF ↗ |
| K240687 | SofWave System | Sofwave Medical, Ltd. | 2024-05-30 | Traditional | PDF ↗ |
| K233996 | Ulthera System (UC-1 Control Unit PRIME) | Ulthera, Inc. | 2024-02-22 | Special | PDF ↗ |
| K233104 | SofWave System | Sofwave Medical, Ltd. | 2023-12-22 | Traditional | PDF ↗ |
| K232455 | SofWave System | Sofwave Medical, Ltd. | 2023-12-14 | Traditional | PDF ↗ |
| K230100 | SCIZER (SC1-M410) | Classys, Inc. | 2023-11-03 | Traditional | PDF ↗ |
| K231628 | BeShape One Device | Beshape Technologies , Ltd. | 2023-09-29 | Traditional | PDF ↗ |
| K231537 | SofWave System | Sofwave Medical, Ltd. | 2023-08-28 | Traditional | PDF ↗ |
| K230820 | SofWave System | Sofwave Medical, Ltd. | 2023-04-18 | Special | PDF ↗ |
| K230019 | SofWave System | Sofwave Medical, Ltd. | 2023-03-14 | Traditional | PDF ↗ |
| K223237 | SofWave System | Sofwave Medical, Ltd. | 2022-12-16 | Traditional | PDF ↗ |
| K211483 | SofWave System | Sofwave Medical, Ltd. | 2021-11-15 | Traditional | PDF ↗ |
| K181896 | LIPOcel | Jeisys Medical, Inc. | 2019-10-18 | Traditional | PDF ↗ |
| K191421 | Sofacia System | Sofwave Medical, Ltd. | 2019-09-09 | Traditional | PDF ↗ |
| K180623 | Ulthera System | Ulthera, Inc. | 2018-05-04 | Traditional | PDF ↗ |
| K170370 | ULTRASHAPE POWER SYSTEM | Syneron Medical, Ltd. | 2017-05-15 | Traditional | PDF ↗ |
| K162163 | UltraShape System | Syneron Medical, Ltd. | 2016-11-17 | Traditional | PDF ↗ |
| K161952 | UltraShape System | Syneron Medical, Ltd. | 2016-11-07 | Traditional | PDF ↗ |
| K160896 | ULTRASHAPE POWER SYSTEM | Syneron Medical, Ltd. | 2016-07-08 | Traditional | PDF ↗ |
| K141708 | ULTRASHAPE SYSTEM | Syneron Medical, Ltd. | 2014-10-06 | Traditional | PDF ↗ |
| K134032 | ULTHERA SYSTEM | Ulthera, Inc. | 2014-06-20 | Traditional | PDF ↗ |
| K133238 | CONTOUR I V3.1 SYSTEM | Syneron Medical, Ltd. | 2014-04-10 | Traditional | PDF ↗ |
| K132028 | ULTHERA SYSTEM | Ulthera, Inc. | 2013-12-11 | Traditional | PDF ↗ |
| K121700 | ULTHERA SYSTEM | Ulthera, Inc. | 2012-10-02 | Traditional | PDF ↗ |
| K122528 | ULTHERA SYSTEM | Ulthera, Inc. | 2012-08-28 | Traditional | PDF ↗ |
| K112626 | LIPSONIX(R) SYSTEM MODEL 2 | Medicis Technologies Corporation | 2011-10-20 | Special | PDF ↗ |
| K100874 | LIPOSONIX SYSTEM, MODEL 1 P00XXXX | Medicis Technologies Corporation | 2011-08-19 | Traditional | PDF ↗ |
| DEN080006 | ULTHERA SYSTEM, MODEL 8850-0001 | Ulthera, Inc. | 2009-09-11 | Post-NSE | — |
Product code OHV · Class II · General, Plastic Surgery. Data: openFDA.