The Luminance RED Acne Device

Over-the-counter Powered Light Based Laser For Acne

Luminance Medical Ventures, Inc.

The following data is part of a premarket notification filed by Luminance Medical Ventures, Inc. with the FDA for The Luminance Red Acne Device.

Pre-market Notification Details

Device IDK220729
510k NumberK220729
Device Name:The Luminance RED Acne Device
ClassificationOver-the-counter Powered Light Based Laser For Acne
Applicant Luminance Medical Ventures, Inc. 2310 Henderson Avenue #1297 Dallas,  TX  75201
ContactTroy Stites
CorrespondentLaura Nygard
leanRAQA, LLC 131 E Loch Lomond Dr Oro Valley,  AZ  85737
Product CodeOLP  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-03-14
Decision Date2022-06-09

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