DeviceClearance

Product code OHV— General, Plastic Surgery

SofWave System

Classification name
Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption
Device class
Class 2
Regulation
21 CFR 878.4590
Advisory panel
General, Plastic Surgery
Total cleared
30
First cleared
Most recent

FDA classification 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.”

— U.S. Food and Drug Administration, device classification record for product code OHV under 21 CFR 878.4590, via openFDA

Market context for product code OHV

FDA has cleared 30 devices under product code OHV between 2009 and 2026, filed by 7 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

last 15 years

Top applicants under product code OHV

Recent clearances under product code OHV

Data sourced from openFDA. This site is unofficial and independent of the FDA.