OHV

Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption

Product code

OHV

Device name

Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption

Device class

Class 2

21 CFR

21 CFR 878.4590

Medical specialty

General, Plastic Surgery

Marketing pathway

510(K)

510(k) clearances (last 3 years)

30

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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (9)

Last three years. Most recent: 2026-05-21.

9 summaries are archived here for direct download.