Dermalux Tri-Wave MD

Powered Laser Surgical Instrument

Aesthetic Technology Ltd.

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

Pre-market Notification Details

Device IDK200659
510k NumberK200659
Device Name:Dermalux Tri-Wave MD
ClassificationPowered Laser Surgical Instrument
Applicant Aesthetic Technology Ltd. 211 Europa Blvd. Warrington,  GB Wa5 7tn
ContactDale Needham
CorrespondentRichard Hamer
Richard Hamer Associates LLC 705 Spring Lakes Blvd Bradenton,  FL  34210
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-03-12
Decision Date2020-05-09

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