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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lamp, Infrared, Therapeutic Heating
510(k) Number K202028
Device Name dermalux Flex MD
Applicant
Aesthetic Technology, Ltd.
Unit 211
Europa Blvd.
Warrington,  GB WA5 7TN
Applicant Contact Dale Needham
Correspondent
Richard Hamer Associates, LLC
705 Spring Lakes Blvd.
Bradenton,  FL  34210
Correspondent Contact Richard Hamer
Regulation Number890.5500
Classification Product Code
ILY  
Subsequent Product Codes
GEX   OHS   OLP  
Date Received07/22/2020
Decision Date 12/16/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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