OHV · Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption
General, Plastic Surgery · 21 CFR 878.4590 · Class 2
Overview
| Product Code | OHV |
|---|---|
| Device Name | Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption |
| Regulation | 21 CFR 878.4590 |
| Device Class | Class 2 |
| Review Panel | General, Plastic Surgery |
Identification
A Focused Ultrasound Stimulator System for Aesthetic Use is 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 noninvasive aesthetic use.
Classification Rationale
Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Focused Ultrasound Stimulator System for Aesthetic Use.” See § 878.1(e) for the availability of this guidance document.
Special Controls
*Classification.* Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Focused Ultrasound Stimulator System for Aesthetic Use.” See § 878.1(e) for the availability of this guidance document.
Recent Cleared Devices (20 of 29)
Showing 20 most recent of 29 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K250418 | Ulthera System (UC-1 Control Unit PRIME Model 2.1) | Ulthera, Inc. | May 13, 2025 | SESE |
| K243035 | Ulthera® System | Ulthera, Inc. | Feb 24, 2025 | SESE |
| K240687 | SofWave System | Sofwave Medical, Ltd. | May 30, 2024 | SESE |
| K233996 | Ulthera System (UC-1 Control Unit PRIME) | Ulthera, Inc. | Feb 22, 2024 | SESE |
| K233104 | SofWave System | Sofwave Medical, Ltd. | Dec 22, 2023 | SESE |
| K232455 | SofWave System | Sofwave Medical, Ltd. | Dec 14, 2023 | SESE |
| K230100 | SCIZER (SC1-M410) | Classys, Inc. | Nov 3, 2023 | SESE |
| K231628 | BeShape One Device | Beshape Technologies , Ltd. | Sep 29, 2023 | SESE |
| K231537 | SofWave System | Sofwave Medical, Ltd. | Aug 28, 2023 | SESE |
| K230820 | SofWave System | Sofwave Medical, Ltd. | Apr 18, 2023 | SESE |
| K230019 | SofWave System | Sofwave Medical, Ltd. | Mar 14, 2023 | SESE |
| K223237 | SofWave System | Sofwave Medical, Ltd. | Dec 16, 2022 | SESE |
| K211483 | SofWave System | Sofwave Medical, Ltd. | Nov 15, 2021 | SESE |
| K181896 | LIPOcel | Jeisys Medical, Inc. | Oct 18, 2019 | SESE |
| K191421 | Sofacia System | Sofwave Medical, Ltd. | Sep 9, 2019 | SESE |
| K180623 | Ulthera System | Ulthera, Inc. | May 4, 2018 | SESE |
| K170370 | ULTRASHAPE POWER SYSTEM | Syneron Medical, Ltd. | May 15, 2017 | SESE |
| K162163 | UltraShape System | Syneron Medical, Ltd. | Nov 17, 2016 | SESE |
| K161952 | UltraShape System | Syneron Medical, Ltd. | Nov 7, 2016 | SESE |
| K160896 | ULTRASHAPE POWER SYSTEM | Syneron Medical, Ltd. | Jul 8, 2016 | SESE |
Top Applicants
- Sofwave Medical, Ltd. — 9 clearances
- Ulthera, Inc. — 9 clearances
- Syneron Medical, Ltd. — 6 clearances
- Medicis Technologies Corporation — 2 clearances
- Beshape Technologies , Ltd. — 1 clearance
