ReVive Light Therapy LED Cleansing System

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 Light Therapy Led Cleansing System.

Pre-market Notification Details

Device IDK221430
510k NumberK221430
Device Name:ReVive Light Therapy LED Cleansing System
ClassificationLight Based Over The Counter Wrinkle Reduction
Applicant LED Technologies, Inc. 12821 Starkey Rd., Suite 4900 Largo,  FL  33773
ContactJelena Barbaric
CorrespondentJelena Barbaric
LED Technologies, Inc. 12821 Starkey Rd., Suite 4900 Largo,  FL  33773
Product CodeOHS  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-05-17
Decision Date2022-07-27

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