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PKO — Transparent Patch For Use In Treatment Of Tattoos Class II

FDA Device Classification

Classification Details

Product Code
PKO
Device Class
Class II
Regulation Number
878.4810
Submission Type
Review Panel
SU
Medical Specialty
General, Plastic Surgery
Implant
No

Definition

To reduce formation of bubbles during laser treatment of tattoos.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K172689merz north americaDESCRIBE PFD PatchNovember 29, 2017
K150212on light sciencesDeScribe Transparent PFD PatchApril 20, 2015