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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 K102477
Device Name NO!NO! SKIN
Applicant
Radiancy (Israel) , Ltd.
5 Hanagar St.
Hod Hasharon,  IL 45240
Applicant Contact ROTHMAN JULIA
Correspondent
Radiancy (Israel) , Ltd.
5 Hanagar St.
Hod Hasharon,  IL 45240
Correspondent Contact ROTHMAN JULIA
Regulation Number878.4810
Classification Product Code
OLP  
Date Received08/30/2010
Decision Date 10/04/2010
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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