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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Over-The-Counter Powered Light Based Laser For Acne
510(k) Number K214103
Device Name Shani Darden LED light therapy mask
Applicant
Harpar Grace International
Unit 4 Imperial Court, Magellan Close, Walworth Business
Park, Hampshire
Andover,  GB SP10 5NT
Applicant Contact Alana Marie Chalmers
Correspondent
Ismart Developments, Ltd.
129 Green Lanes, Sutton Coldfield
Birmingham,  GB B735TR
Correspondent Contact Susan D'Arcy
Regulation Number878.4810
Classification Product Code
OLP  
Subsequent Product Code
OHS  
Date Received12/29/2021
Decision Date 03/22/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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