OHV · Class II · 21 CFR 878.4590

FDA Product Code OHV: Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption

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.

Leading manufacturers include Sofwave Medical, Ltd., Ulthera, Inc. and Jeisys Medical, Inc..

30
Total
29
Cleared
145d
Avg days
2009
Since
Declining activity - 3 submissions in the last 2 years vs 10 in the prior period
Review times improving: avg 108d recently vs 149d historically

FDA 510(k) Cleared Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption Devices (Product Code OHV)

30 devices
1–24 of 30
Cleared May 21, 2026
Ulthera® System
K260618
Ulthera, Inc.
General & Plastic Surgery · 85d
Cleared May 13, 2025
Ulthera System (UC-1 Control Unit PRIME Model 2.1)
K250418
Ulthera, Inc.
General & Plastic Surgery · 89d
Cleared Feb 24, 2025
Ulthera® System
K243035
Ulthera, Inc.
General & Plastic Surgery · 150d
Cleared May 30, 2024
SofWave System
K240687
Sofwave Medical, Ltd.
General & Plastic Surgery · 79d
Cleared Feb 22, 2024
Ulthera System (UC-1 Control Unit PRIME)
K233996
Ulthera, Inc.
General & Plastic Surgery · 66d
Cleared Dec 22, 2023
SofWave System
K233104
Sofwave Medical, Ltd.
General & Plastic Surgery · 87d
Cleared Dec 14, 2023
SofWave System
K232455
Sofwave Medical, Ltd.
Physical Medicine · 122d
Cleared Nov 03, 2023
SCIZER (SC1-M410)
K230100
Classys, Inc.
General & Plastic Surgery · 294d
Cleared Sep 29, 2023
BeShape One™ Device
K231628
Beshape Technologies , Ltd.
General & Plastic Surgery · 116d
Cleared Aug 28, 2023
SofWave System
K231537
Sofwave Medical, Ltd.
General & Plastic Surgery · 90d
Cleared Apr 18, 2023
SofWave System
K230820
Sofwave Medical, Ltd.
General & Plastic Surgery · 25d
Cleared Mar 14, 2023
SofWave System
K230019
Sofwave Medical, Ltd.
General & Plastic Surgery · 70d
Cleared Dec 16, 2022
SofWave System
K223237
Sofwave Medical, Ltd.
General & Plastic Surgery · 58d
Cleared Nov 15, 2021
SofWave System
K211483
Sofwave Medical, Ltd.
General & Plastic Surgery · 187d
Cleared Oct 18, 2019
LIPOcel
K181896
Jeisys Medical, Inc.
General & Plastic Surgery · 459d
Cleared Sep 09, 2019
Sofacia System
K191421
Sofwave Medical, Ltd.
General & Plastic Surgery · 104d
Cleared May 04, 2018
Ulthera System
K180623
Ulthera, Inc.
General & Plastic Surgery · 56d

About Product Code OHV - Regulatory Context

510(k) Submission Activity

30 total 510(k) submissions under product code OHV since 2009, with 29 receiving FDA clearance (average review time: 145 days).

Submission volume has declined in recent years - 3 submissions in the last 24 months compared to 10 in the prior period.

FDA 510(k) Review Time - OHV Product Code

Recent submissions under OHV have taken an average of 108 days to reach a decision - down from 149 days historically, suggesting improved FDA processing for this classification.

OHV devices are reviewed by the General & Plastic Surgery panel. Browse all General & Plastic Surgery devices →