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 Classys, Inc..
FDA 510(k) Cleared Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption Devices (Product Code OHV)
About Product Code OHV - Regulatory Context
510(k) Submission Activity
29 total 510(k) submissions under product code OHV since 2009, with 28 receiving FDA clearance (average review time: 147 days).
Submission volume has declined in recent years - 3 submissions in the last 24 months compared to 9 in the prior period.
FDA Review Time
Recent submissions under OHV have taken an average of 106 days to reach a decision - down from 152 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 →