ReVive Perioral

Light Based Over The Counter Wrinkle Reduction

LED Technologies, Inc.

The following data is part of a premarket notification filed by Led Technologies, Inc. with the FDA for Revive Perioral.

Pre-market Notification Details

Device IDK172662
510k NumberK172662
Device Name:ReVive Perioral
ClassificationLight Based Over The Counter Wrinkle Reduction
Applicant LED Technologies, Inc. 6000 Greenwood Plaza Blvd., Suite 110 Greenwood Village,  CO  80111
ContactLloyd Nelson
CorrespondentJelena Barbaric
LED Technologies, Inc. 6000 Greenwood Plaza Blvd., Suite 110 Greenwood Village,  CO  80111
Product CodeOHS  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-09-05
Decision Date2018-01-09
Summary:summary

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