DeviceClearance

Product code PKO— General, Plastic Surgery

DESCRIBE PFD Patch

Classification name
Transparent Patch For Use In Treatment Of Tattoos
Device class
Class 2
Regulation
21 CFR 878.4810
Advisory panel
General, Plastic Surgery
Total cleared
2
First cleared
Most recent

FDA classification definition

“To reduce formation of bubbles during laser treatment of tattoos.”

— U.S. Food and Drug Administration, device classification record for product code PKO under 21 CFR 878.4810, via openFDA

Market context for product code PKO

FDA has cleared 2 devices under product code PKO between 2015 and 2017, filed by 2 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 PKO

Recent clearances under product code PKO

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