Omnilux CLEAR

Over-the-counter Powered Light Based Laser For Acne

GlobalMed Technologies

The following data is part of a premarket notification filed by Globalmed Technologies with the FDA for Omnilux Clear.

Pre-market Notification Details

Device IDK210948
510k NumberK210948
Device Name:Omnilux CLEAR
ClassificationOver-the-counter Powered Light Based Laser For Acne
Applicant GlobalMed Technologies 163 Camino Dorado, Ste B Napa,  CA  94558
ContactLisa Thorson
CorrespondentLisa Thorson
GlobalMed Technologies 163 Camino Dorado, Ste B Napa,  CA  94558
Product CodeOLP  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductYes
Date Received2021-03-30
Decision Date2021-06-24

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
05060534510234 K210948 000

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