Dermalux Flex MD

Lamp, Infrared, Therapeutic Heating

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 IDK202028
510k NumberK202028
Device Name:Dermalux Flex MD
ClassificationLamp, Infrared, Therapeutic Heating
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 CodeILY  
Subsequent Product CodeGEX
Subsequent Product CodeOHS
Subsequent Product CodeOLP
CFR Regulation Number890.5500 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-07-22
Decision Date2020-12-16

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