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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Light Based Over The Counter Wrinkle Reduction
510(k) Number K231555
Device Name LUMA LED patches (LUMA Blemish (TN2197) and LUMA Revive (TN2189))
Applicant
Ismart Developments, Ltd.
129 Green Lanes, Boldmere, Sutton Coldfield
Birmingham,  GB B73 5LT
Applicant Contact Susan D'Arcy
Correspondent
Ismart Developments, Ltd.
129 Green Lanes, Boldmere, Sutton Coldfield
Birmingham,  GB B73 5LT
Correspondent Contact Susan D'Arcy
Regulation Number878.4810
Classification Product Code
OHS  
Subsequent Product Code
OLP  
Date Received05/30/2023
Decision Date 07/27/2023
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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