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510(k) K172689

DESCRIBE PFD Patch by Merz North America, Inc. — Product Code PKO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 29, 2017
Date Received
September 6, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Transparent Patch For Use In Treatment Of Tattoos
Device Class
Class II
Regulation Number
878.4810
Review Panel
SU
Submission Type

To reduce formation of bubbles during laser treatment of tattoos.

Other clearances for product code PKO

  • K150212 — DeScribe Transparent PFD Patch (April 20, 2015)