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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
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