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

Skin Resurfacing Rf Applicator

21 CFR 878.4400 / General, Plastic Surgery
FDA source (opens on fda.gov)

OUH is the FDA product code for Skin Resurfacing Rf Applicator, a class II device type, regulated under 21 CFR 878.4400. FDA's definition for this code reads: "Skin resurfacing". As of , FDA records hold 5 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
OUH
Device name
Skin Resurfacing Rf Applicator
FDA definition
Skin resurfacing
Regulation
21 CFR 878.4400
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
5
Ingested recalls
1

Clearances, product code OUH

By decision year
5 clearances under product code OUH with a decision year between 2011 and 2016, 2011 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code OUH by decision year
YearClearances
20111
20121
20141
20151
20161

Applicants with the most clearances

Product code OUH
Applicants holding the most 510(k) clearances under product code OUH
ApplicantClearances
Endymed Medical Inc.3
Jeisys Medical Inc.1
Sung Hwan E&B Co.,Ltd1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 17 companies shown, in name order