Panels › General, Plastic Surgery › Product code OHV · Class 2
Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption
Regulation 878.4590
1510(k)s in 12 months (30 all time)
0recalls in 12 months (1 all time)
0recalls that name a 510(k)
Top companies in OHV
| Company | 510(k)s | Recalls |
|---|---|---|
| Ulthera, Inc. | 10 | 0 |
| Sofwave Medical, Ltd. | 9 | 0 |
| Syneron Medical, Ltd. | 6 | 0 |
| Medicis Technologies Corporation | 2 | 0 |
| Beshape Technologies , Ltd. | 1 | 0 |
| Classys, Inc. | 1 | 0 |
| Jeisys Medical, Inc. | 1 | 0 |
| RoyalVibe Health Ltd. | 0 | 1 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 21, 2026 | K260618 | Ulthera® System Ulthera, Inc. | OHV |
| May 13, 2025 | K250418 | Ulthera System (UC-1 Control Unit PRIME Model 2.1) Ulthera, Inc. | OHV |
| Feb 24, 2025 | K243035 | Ulthera® System Ulthera, Inc. | OHV |
| May 30, 2024 | K240687 | SofWave System Sofwave Medical, Ltd., IL | OHV |
| Feb 22, 2024 | K233996 | Ulthera System (UC-1 Control Unit PRIME) Ulthera, Inc. | OHV |
| Dec 22, 2023 | K233104 | SofWave System Sofwave Medical, Ltd., IL | OHV |
| Dec 14, 2023 | K232455 | SofWave System Sofwave Medical, Ltd., IL | OHV |
| Nov 3, 2023 | K230100 | SCIZER (SC1-M410) Classys, Inc., KR | OHV |
| Sep 29, 2023 | K231628 | BeShape One Device Beshape Technologies , Ltd., IL | OHV |
| Aug 28, 2023 | K231537 | SofWave System Sofwave Medical, Ltd., IL | OHV |
| Apr 18, 2023 | K230820 | SofWave System Sofwave Medical, Ltd., IL | OHV |
| Mar 14, 2023 | K230019 | SofWave System Sofwave Medical, Ltd., IL | OHV |
| Dec 16, 2022 | K223237 | SofWave System Sofwave Medical, Ltd., IL | OHV |
| Nov 15, 2021 | K211483 | SofWave System Sofwave Medical, Ltd., IL | OHV |
| Oct 18, 2019 | K181896 | LIPOcel Jeisys Medical, Inc., KR | OHV |
| Sep 9, 2019 | K191421 | Sofacia System Sofwave Medical, Ltd., IL | OHV |
| May 4, 2018 | K180623 | Ulthera System Ulthera, Inc. | OHV |
| May 15, 2017 | K170370 | ULTRASHAPE POWER SYSTEM Syneron Medical, Ltd., IL | OHV |
| Nov 17, 2016 | K162163 | UltraShape System Syneron Medical, Ltd., IL | OHV |
| Nov 7, 2016 | K161952 | UltraShape System Syneron Medical, Ltd., IL | OHV |
| Jul 8, 2016 | K160896 | ULTRASHAPE POWER SYSTEM Syneron Medical, Ltd., IL | OHV |
| Oct 6, 2014 | K141708 | ULTRASHAPE SYSTEM Syneron Medical, Ltd. | OHV |
| Jun 20, 2014 | K134032 | ULTHERA SYSTEM Ulthera, Inc. | OHV |
| Apr 10, 2014 | K133238 | CONTOUR I V3.1 SYSTEM Syneron Medical, Ltd. | OHV |
| Dec 11, 2013 | K132028 | ULTHERA SYSTEM Ulthera, Inc. | OHV |
| Oct 2, 2012 | K121700 | ULTHERA SYSTEM Ulthera, Inc. | OHV |
| Aug 28, 2012 | K122528 | ULTHERA SYSTEM Ulthera, Inc. | OHV |
| Oct 20, 2011 | K112626 | LIPSONIX(R) SYSTEM MODEL 2 Medicis Technologies Corporation | OHV |
| Aug 19, 2011 | K100874 | LIPOSONIX SYSTEM, MODEL 1 P00XXXX Medicis Technologies Corporation | OHV |
| Sep 11, 2009 | DEN080006 | ULTHERA SYSTEM, MODEL 8850-0001 Ulthera, Inc. | OHV |
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