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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transparent Patch For Use In Treatment Of Tattoos
510(k) Number K150212
Device Name DeScribe Transparent PFD Patch
Applicant
On Light Sciences, Inc.
7852 Starward Dr.
Dublin,  CA  94568
Applicant Contact David Sell
Correspondent
On Light Sciences, Inc.
131 Kelekent Ln.
Cary,  NC  27518
Correspondent Contact Marcy Moore
Regulation Number878.4810
Classification Product Code
PKO  
Date Received01/30/2015
Decision Date 04/20/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Clinical Trials NCT02297321
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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