OUPClass II

Powered Surgical Instrument For Improvement In The Appearance Of Cellulite

General, Plastic Surgery · 21 CFR 878.4790

Used for controlled release of subcutaneous tissue for improvement in the appearance of cellulite.

MDR events79All time

Recalls1All time

Registered firms21Currently listed

510(k) clearances9All time

Recent MDR events

79 adverse event reports on file

Event type breakdown

Injury69

Malfunction10

Most-reported manufacturers

Revelle Aesthetics, Inc.30 Ulthera, Inc., Merz Device Innovation Center25 Merz North America, Inc.17 Ulthera Inc, Merz Device Innovation Center2 Merz / Ulthera, Inc.1 Ulthera Inc.1 Ulthera, Inc1 Ulthera, Inc.1

Recalls

1 recall events for this product code

Ulthera Inc
TerminatedDec 13, 2016
Cellfina Prep Pack, Part No. CP1
It was discovered that a non-sterile vacuum tube is supplied within the pack, although the Instructions for Use (IFU) describe the use of a sterile vacuum tube as part of the procedure setup.
Z-0749-2017 · View FDA record ↗

Registered firms

21 firms currently registered for this product code

510(k) clearances

9 clearances for this product code