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OUH — Skin Resurfacing Rf Applicator Class II

FDA Device Classification

Classification Details

Product Code
OUH
Device Class
Class II
Regulation Number
878.4400
Submission Type
Review Panel
SU
Medical Specialty
General, Plastic Surgery
Implant
No

Definition

Skin resurfacing

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K150409sung hwan e and b coVIVACE Electrosurgical SystemJanuary 15, 2016
K142833jeisys medicalINTRAGenJune 4, 2015
K130501endymed medicalINTENSIFMarch 13, 2014
K120513endymed medicalGLOW BY ENDYMEDMay 8, 2012
K101510endymed medicalFRACTIONAL SKIN RESURFACING (FSR) APPLICATORFebruary 17, 2011