OHVClass II

Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption

General, Plastic Surgery · 21 CFR 878.4590

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.

MDR events216All time

Recalls1All time

Registered firms49Currently listed

510(k) clearances30All time

Recent MDR events

216 adverse event reports on file

Event type breakdown

Injury205

Malfunction10

Unspecified1

Most-reported manufacturers

Merz North America, Inc.54 Ulthera, Inc., Merz Device Innovation Center26 Sofwave Medical Ltd.16 Solta Medical16 Ulthera16 Ulthera, Inc.14 Solta Medical Inc.12 Ulthera Inc.12

Recalls

1 recall events for this product code

RoyalVibe Health Ltd.
Open, ClassifiedOct 6, 2023
CellQuicken Analyzer (Smart-Watch and Software),
Ultrasound devices were not authorized, cleared, or approved by FDA, and thus their performance characteristics have not been adequately established. There is a possibility of customers' reliance on marketing claims which could cause the user to forgo medical treatment resulting in health consequences.
Z-0082-2024 · View FDA record ↗

Registered firms

49 firms currently registered for this product code

510(k) clearances

30 clearances for this product code