OUH · Class II · 21 CFR 878.4400

FDA Product Code OUH: Skin Resurfacing Rf Applicator

Skin Resurfacing

Leading manufacturers include Endymed Medical, Ltd., Jeisys Medical, Inc. and Sung Hwan E&B Co.,Ltd.

5
Total
5
Cleared
259d
Avg days
2011
Since

FDA 510(k) Cleared Skin Resurfacing Rf Applicator Devices (Product Code OUH)

5 devices
1–5 of 5
Cleared Jan 15, 2016
VIVACE Electrosurgical System
K150409
Sung Hwan E&B Co.,Ltd
General & Plastic Surgery · 331d
Cleared Jun 04, 2015
INTRAGen
K142833
Jeisys Medical, Inc.
General & Plastic Surgery · 247d
Cleared Mar 13, 2014
INTENSIF
K130501
Endymed Medical, Ltd.
General & Plastic Surgery · 379d
Cleared May 08, 2012
GLOW BY ENDYMED
K120513
Endymed Medical, Ltd.
General & Plastic Surgery · 77d
Cleared Feb 17, 2011
FRACTIONAL SKIN RESURFACING (FSR) APPLICATOR
K101510
Endymed Medical, Ltd.
General & Plastic Surgery · 261d

About Product Code OUH - Regulatory Context