Data / Medical devices / Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption
Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption (OHV): 10 FDA-registered makers in 3 countries
10 establishments in 3 countries are registered with the FDA to make Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption (product code OHV, Class 2, 21 CFR 878.4590). 5 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 30 510(k) clearances under this code, the latest on May 21, 2026, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.
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- Product code
- OHV
- Device class
- 2
- Regulation
- 878.4590
- Medical specialty
- General, Plastic Surgery
Makers by country
| Country | Makers |
|---|---|
| United States | 5 |
| Israel | 3 |
| South Korea | 2 |
Makers of Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Ulthera Inc | Raleigh, NC, United States | Specification developer | 10 | May 21, 2026 | 0 | 0 | 0 | api.fda.gov |
| Sofwave Medical Ltd. | Yokneam Illit Northern, Israel | Exporter to the US, Manufacturer, Specification developer | 9 | May 30, 2024 | 0 | 0 | 0 | api.fda.gov |
| Preferred Depot | Irvine, CA, United States | Remanufacturer, Repackager or relabeler | 3 | May 30, 2024 | 0 | 0 | 0 | api.fda.gov |
| Classys Inc | Republic of Korea Seoul, South Korea | Manufacturer | 1 | November 3, 2023 | 0 | 0 | 0 | api.fda.gov |
| Jeisys Medical Inc. | Seoul, South Korea | Manufacturer | 1 | October 18, 2019 | 0 | 0 | 0 | api.fda.gov |
| Benchmark Electronics, Inc. | Winona, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cao Group, Inc. | W Jordan, UT, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jabil Inc. | Auburn Hills, MI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| R.H. Electronics Ltd. | Nof Hagalil Northern, Israel | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Usr Electronic Systems (1987) Ltd | Karmiel Northern, Israel | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated May 21, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.