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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 K121435
Device Name SILKN BLUE
Applicant
Home Skinovations , Ltd.
Tavor Buld. Pob 533
Yokneam Illit,  IL 20692
Applicant Contact AMIR WALDMAN
Correspondent
Home Skinovations , Ltd.
Tavor Buld. Pob 533
Yokneam Illit,  IL 20692
Correspondent Contact AMIR WALDMAN
Regulation Number878.4810
Classification Product Code
OLP  
Date Received05/14/2012
Decision Date 02/22/2013
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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