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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 K213184
Device Name MZ Skin LightMAX Supercharged LED Mask 2.0
Applicant
Mz Skin
110-112 Kings Rd., First Floor
London,  GB SW3 4TX
Applicant Contact Maryam Zamani
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 Received09/29/2021
Decision Date 11/23/2021
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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