ReVive Light Therapy LED Cleansing System

Over-the-counter Powered Light Based Laser For Acne

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 IDK180447
510k NumberK180447
Device Name:ReVive Light Therapy LED Cleansing System
ClassificationOver-the-counter Powered Light Based Laser For Acne
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 CodeOLP  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-02-20
Decision Date2018-06-04
Summary:summary

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