510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K172689Substantially Equivalent

DESCRIBE PFD Patch

Merz North America, Inc., Raleigh NC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K172689 is the FDA 510(k) clearance record for DESCRIBE PFD Patch, a class II device, cleared for Merz North America, Inc. on under FDA product code PKO (Transparent Patch For Use In Treatment Of Tattoos). FDA's definition for product code PKO reads: "To reduce formation of bubbles during laser treatment of tattoos". FDA records list 15 510(k) clearances for Merz North America, Inc., from to . As of , FDA records show no recalls naming K172689.

Clearance record

Decision date
Received
(84 days to decision)
Product code
PKO Transparent Patch For Use In Treatment Of Tattoos
Regulation
21 CFR 878.4810
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Merz North America, Inc. 6501 Six Forks Rd., Raleigh NC
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PKO

Trailing 12 months

FDA records hold no clearances under product code PKO in the trailing twelve months.

FDA records show no clearances under product code PKO in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code PKO, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260