DeviceClearance

Product code OUH— General, Plastic Surgery

FRACTIONAL SKIN RESURFACING (FSR) APPLICATOR

Classification name
Skin Resurfacing Rf Applicator
Device class
Class 2
Regulation
21 CFR 878.4400
Advisory panel
General, Plastic Surgery
Total cleared
5
First cleared
Most recent

FDA classification definition

“Skin resurfacing”

— U.S. Food and Drug Administration, device classification record for product code OUH under 21 CFR 878.4400, via openFDA

Market context for product code OUH

FDA has cleared 5 devices under product code OUH between 2011 and 2016, filed by 3 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code OUH

Recent clearances under product code OUH

Data sourced from openFDA. This site is unofficial and independent of the FDA.