DeScribe Transparent PFD Patch

Transparent Patch For Use In Treatment Of Tattoos

ON Light Sciences, Inc.

The following data is part of a premarket notification filed by On Light Sciences, Inc. with the FDA for Describe Transparent Pfd Patch.

Pre-market Notification Details

Device IDK150212
510k NumberK150212
Device Name:DeScribe Transparent PFD Patch
ClassificationTransparent Patch For Use In Treatment Of Tattoos
Applicant ON Light Sciences, Inc. 7852 Starward Dr. Dublin,  CA  94568
ContactDavid Sell
CorrespondentMarcy Moore
ON Light Sciences, Inc. 131 Kelekent Lane Cary,  NC  27518
Product CodePKO  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-01-30
Decision Date2015-04-20
Summary:summary

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