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

Transparent Patch For Use In Treatment Of Tattoos

21 CFR 878.4810 / General, Plastic Surgery
FDA source (opens on fda.gov)

PKO is the FDA product code for Transparent Patch For Use In Treatment Of Tattoos, a class II device type, regulated under 21 CFR 878.4810. FDA's definition for this code reads: "To reduce formation of bubbles during laser treatment of tattoos". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
PKO
Device name
Transparent Patch For Use In Treatment Of Tattoos
FDA definition
To reduce formation of bubbles during laser treatment of tattoos.
Regulation
21 CFR 878.4810
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
2
Ingested recalls
0

Clearances, product code PKO

By decision year
2 clearances under product code PKO with a decision year between 2015 and 2017, 2015 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code PKO by decision year
YearClearances
20151
20171

Applicants with the most clearances

Product code PKO
Applicants holding the most 510(k) clearances under product code PKO
ApplicantClearances
Merz North America, Inc.1
On Light Sciences, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code