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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 K223147
Device Name myLEDmask
Applicant
Myblend
9 Rue Du Commandant Pilot
Neuilly-Sur-Seine,  FR 92200
Applicant Contact Clédia Hettinger
Correspondent
Ceiso
69 Rue De Paris Hall B
Orsay,  FR 91400
Correspondent Contact José Perez
Regulation Number878.4810
Classification Product Code
OHS  
Date Received10/05/2022
Decision Date 05/14/2023
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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