OUHClass II

Skin Resurfacing Rf Applicator

General, Plastic Surgery · 21 CFR 878.4400

Skin resurfacing

MDR events8All time

Recalls1All time

Registered firms35Currently listed

510(k) clearances5All time

Recent MDR events

8 adverse event reports on file

Event type breakdown

Injury7

Unspecified1

Most-reported manufacturers

Cartessa Aesthetics2 Aesthetics Biomedical Inc.1 Aesthetics Biomedical, Inc.1 Cutera, Inc.1 Medicreations1 Shenb1 Unknown1

Recalls

1 recall events for this product code

Aesthetics Biomedical, Inc.
TerminatedUnknown
SUNG HWAN E&B VIVACE Shenb Innovation of Beauty Technologyt - Product Usage: intended for use in the dermatologic and surgical procedures for electrocoagulatio
A high frequency output (2 MHz) has not been cleared for distribution in the U.S.
Z-0444-2021 · View FDA record ↗

Registered firms

35 firms currently registered for this product code

510(k) clearances

5 clearances for this product code