Dermalux Flex MD

Light Based Over The Counter Wrinkle Reduction

Aesthetic Technology Ltd.

The following data is part of a premarket notification filed by Aesthetic Technology Ltd. with the FDA for Dermalux Flex Md.

Pre-market Notification Details

Device IDK212275
510k NumberK212275
Device Name:Dermalux Flex MD
ClassificationLight Based Over The Counter Wrinkle Reduction
Applicant Aesthetic Technology Ltd. Unit 211 Europa Blvd. Warrington,  GB Wa5 7tn
ContactDale Needham
CorrespondentRichard Hamer
Richard Hamer Associates, LLC 705 Spring Lakes Blvd Bradenton,  FL  34210
Product CodeOHS  
Subsequent Product CodeILY
Subsequent Product CodeOLP
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-07-20
Decision Date2021-11-18

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