OHV
30 FDA 510(k) clearances · Product code
104 daysmedian time to decision
459 days90th percentile
30clearances measured
FDA profile
- Official device name
- Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4590
- Medical specialty
- General, Plastic Surgery
- FDA definition
- A device using focused ultrasound to produce localized, mechanical motion within tissues and cells for the purpose of producing either localized heating for tissue coagulation or for mechanical cellular membrane disruption intended for non-invasive aesthetic use.
- Adverse events (MAUDE)
- 2014: 17 · 2015: 19 · 2016: 29 · 2017: 29 · 2019: 15 · 2025: 21
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Ulthera® System (K260618) | Ulthera, Inc. | 2026-05-21 |
| Ulthera System (UC-1 Control Unit PRIME Model 2.1) (K250418) | Ulthera, Inc. | 2025-05-13 |
| Ulthera® System (K243035) | Ulthera, Inc. | 2025-02-24 |
| SofWave System (K240687) | Sofwave Medical, Ltd. | 2024-05-30 |
| Ulthera System (UC-1 Control Unit PRIME) (K233996) | Ulthera, Inc. | 2024-02-22 |
| SofWave System (K233104) | Sofwave Medical, Ltd. | 2023-12-22 |
| SofWave System (K232455) | Sofwave Medical, Ltd. | 2023-12-14 |
| SCIZER (SC1-M410) (K230100) | Classys, Inc. | 2023-11-03 |
| BeShape One™ Device (K231628) | Beshape Technologies , Ltd. | 2023-09-29 |
| SofWave System (K231537) | Sofwave Medical, Ltd. | 2023-08-28 |
| SofWave System (K230820) | Sofwave Medical, Ltd. | 2023-04-18 |
| SofWave System (K230019) | Sofwave Medical, Ltd. | 2023-03-14 |
| SofWave System (K223237) | Sofwave Medical, Ltd. | 2022-12-16 |
| SofWave System (K211483) | Sofwave Medical, Ltd. | 2021-11-15 |
| LIPOcel (K181896) | Jeisys Medical, Inc. | 2019-10-18 |
| Sofacia System (K191421) | Sofwave Medical, Ltd. | 2019-09-09 |
| Ulthera System (K180623) | Ulthera, Inc. | 2018-05-04 |
| ULTRASHAPE POWER SYSTEM (K170370) | Syneron Medical, Ltd. | 2017-05-15 |
| UltraShape System (K162163) | Syneron Medical, Ltd. | 2016-11-17 |
| UltraShape System (K161952) | Syneron Medical, Ltd. | 2016-11-07 |
| ULTRASHAPE POWER SYSTEM (K160896) | Syneron Medical, Ltd. | 2016-07-08 |
| ULTRASHAPE SYSTEM (K141708) | Syneron Medical, Ltd. | 2014-10-06 |
| ULTHERA SYSTEM (K134032) | Ulthera, Inc. | 2014-06-20 |
| CONTOUR I V3.1 SYSTEM (K133238) | Syneron Medical, Ltd. | 2014-04-10 |
| ULTHERA SYSTEM (K132028) | Ulthera, Inc. | 2013-12-11 |
| ULTHERA SYSTEM (K121700) | Ulthera, Inc. | 2012-10-02 |
| ULTHERA SYSTEM (K122528) | Ulthera, Inc. | 2012-08-28 |
| LIPSONIX(R) SYSTEM MODEL 2 (K112626) | Medicis Technologies Corporation | 2011-10-20 |
| LIPOSONIX SYSTEM, MODEL 1 P00XXXX (K100874) | Medicis Technologies Corporation | 2011-08-19 |
| ULTHERA SYSTEM, MODEL 8850-0001 (DEN080006) | Ulthera, Inc. | 2009-09-11 |
Track OHV automatically
Every clearance here is in the API, with alerts when new ones post.