510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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OUPClass II

Powered Surgical Instrument For Improvement In The Appearance Of Cellulite

21 CFR 878.4790 / General, Plastic Surgery
FDA source (opens on fda.gov)

OUP is the FDA product code for Powered Surgical Instrument For Improvement In The Appearance Of Cellulite, a class II device type, regulated under 21 CFR 878.4790. FDA's definition for this code reads: "Used for controlled release of subcutaneous tissue for improvement in the appearance of cellulite". As of , FDA records hold 9 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
OUP
Device name
Powered Surgical Instrument For Improvement In The Appearance Of Cellulite
FDA definition
Used for controlled release of subcutaneous tissue for improvement in the appearance of cellulite.
Regulation
21 CFR 878.4790
Device class
Class II
Review panel
General, Plastic Surgery
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
9
Ingested recalls
1

Clearances, product code OUP

By decision year
9 clearances under product code OUP with a decision year between 2013 and 2023, 2016 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code OUP by decision year
YearClearances
20131
20141
20151
20162
20191
20211
20221
20231

Applicants with the most clearances

Product code OUP
Applicants holding the most 510(k) clearances under product code OUP
ApplicantClearances
Merz North America, Inc.4
Cabochon Aesthetics, Inc.2
Revelle Aesthetics, Inc.2
Nc8, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 16 companies shown, in name order