510(k) K150212

DeScribe Transparent PFD Patch by On Light Sciences, Inc. — Product Code PKO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 20, 2015
Date Received
January 30, 2015
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.