FDA 510(k) Applications for Medical Device Product Code "OHV"
(Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K231628 | BeShape Technologies Ltd. | BeShape OneÖ Device | 09/29/2023 |
| K230100 | Classys Inc | SCIZER (SC1-M410) | 11/03/2023 |
| K181896 | Jeisys Medical, Inc. | LIPOcel | 10/18/2019 |
| K100874 | MEDICIS TECHNOLOGIES CORPORATION | LIPOSONIX SYSTEM, MODEL 1 P00XXXX | 08/19/2011 |
| K112626 | MEDICIS TECHNOLOGIES CORPORATION | LIPSONIX(R) SYSTEM MODEL 2 | 10/20/2011 |
| K230820 | Sofwave Medical Ltd | SofWave System | 04/18/2023 |
| K191421 | Sofwave Medical Ltd. | Sofacia System | 09/09/2019 |
| K240687 | Sofwave Medical Ltd. | SofWave System | 05/30/2024 |
| K223237 | Sofwave Medical Ltd. | SofWave System | 12/16/2022 |
| K230019 | Sofwave Medical Ltd. | SofWave System | 03/14/2023 |
| K231537 | Sofwave Medical Ltd. | SofWave System | 08/28/2023 |
| K232455 | Sofwave Medical Ltd. | SofWave System | 12/14/2023 |
| K233104 | Sofwave Medical Ltd. | SofWave System | 12/22/2023 |
| K211483 | Sofwave Medical Ltd. | SofWave System | 11/15/2021 |
| K133238 | SYNERON MEDICAL LTD | CONTOUR I V3.1 SYSTEM | 04/10/2014 |
| K160896 | SYNERON MEDICAL LTD | ULTRASHAPE POWER SYSTEM | 07/08/2016 |
| K162163 | SYNERON MEDICAL LTD | UltraShape System | 11/17/2016 |
| K170370 | Syneron Medical Ltd. | ULTRASHAPE POWER SYSTEM | 05/15/2017 |
| K141708 | SYNERON MEDICAL LTD. | ULTRASHAPE SYSTEM | 10/06/2014 |
| K161952 | Syneron Medical Ltd. | UltraShape System | 11/07/2016 |
| K250418 | Ulthera Inc. | Ulthera System (UC-1 Control Unit PRIME Model 2.1) | 05/13/2025 |
| K180623 | Ulthera, Inc | Ulthera System | 05/04/2018 |
| K121700 | ULTHERA, INC. | ULTHERA SYSTEM | 10/02/2012 |
| K122528 | ULTHERA, INC. | ULTHERA SYSTEM | 08/28/2012 |
| K132028 | ULTHERA, INC. | ULTHERA SYSTEM | 12/11/2013 |
| K134032 | ULTHERA, INC. | ULTHERA SYSTEM | 06/20/2014 |
| K233996 | Ulthera, Inc. | Ulthera System (UC-1 Control Unit PRIME) | 02/22/2024 |
| DEN080006 | ULTHERA, INC. | ULTHERA SYSTEM, MODEL 8850-0001 | 09/11/2009 |
| K243035 | Ulthera, Inc. | Ulthera« System | 02/24/2025 |
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