FDA product code OHV: Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption
OHV is the FDA product code for focused ultrasound for tissue heat or mechanical cellular disruption. It is a Class II device, regulated under 21 CFR 878.4590 and reviewed by the General and Plastic Surgery panel. FDA has cleared 29 510(k) submissions under OHV, 13 in the last five years, from 7 different applicants. The average 510(k) review took 132 days (median 104); 92 days on average over the last three years. 1 De Novo request was granted under it. FDA has posted 1 recall for OHV devices, 1 initiated in the last five years.
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.
Classification
| Field | Value |
|---|---|
| Device name | Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption |
| Device class | Class II |
| Regulation | 21 CFR 878.4590 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
510(k) clearances per year for OHV
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 98 |
| 2018 | 1 | 56 |
| 2019 | 2 | 282 |
| 2021 | 1 | 187 |
| 2022 | 1 | 58 |
| 2023 | 7 | 115 |
| 2024 | 2 | 72 |
| 2025 | 2 | 120 |
| 2026 | 1 | 85 |
Compare with all 510(k) review times · Search every OHV clearance
Top OHV applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Ulthera, Inc. | 9 | 2026-05-21 |
| Sofwave Medical, Ltd. | 9 | 2024-05-30 |
| Syneron Medical, Ltd. | 6 | 2017-05-15 |
| Medicis Technologies Corporation | 2 | 2011-10-20 |
| Classys, Inc. | 1 | 2023-11-03 |
2 more applicants have OHV clearances. See the full list in Caduvo.
Most recent OHV clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K260618 | Ulthera, Inc. | Ulthera® System | 2026-05-21 | 85 |
| K250418 | Ulthera, Inc. | Ulthera System (UC-1 Control Unit PRIME Model 2.1) | 2025-05-13 | 89 |
| K243035 | Ulthera, Inc. | Ulthera® System | 2025-02-24 | 150 |
| K240687 | Sofwave Medical, Ltd. | SofWave System | 2024-05-30 | 79 |
| K233996 | Ulthera, Inc. | Ulthera System (UC-1 Control Unit PRIME) | 2024-02-22 | 66 |
Recalls for OHV devices
1 product recalls in 1 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2023-08-30.
| Year | Recalls |
|---|---|
| 2023 | 1 |
Frequently asked questions
What is FDA product code OHV?
OHV is the FDA product code for focused ultrasound for tissue heat or mechanical cellular disruption. It is a Class II device, regulated under 21 CFR 878.4590 and reviewed by the General and Plastic Surgery panel.
What device class is OHV?
Class II, regulation 21 CFR 878.4590. Typical premarket route: 510(k).
How long does a 510(k) take for product code OHV?
Across 29 cleared submissions the average was 132 days from receipt to decision (median 104).
Which companies have the most OHV clearances?
Ulthera, Inc. (9); Sofwave Medical, Ltd. (9); Syneron Medical, Ltd. (6); Medicis Technologies Corporation (2); Classys, Inc. (1).
Have OHV devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2023-08-30.
Next steps
- Run an FDA pathway report with predicate devices for product code OHV
- Run a recall and safety report across every OHV manufacturer
- Watch product code OHV for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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