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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 Hair Removal
510(k) Number K103184
Device Name SILK'N FLASH N GO
Applicant
Home Skinovations , Ltd.
Apolo Bldg.
Pob 533
Yokneam Illit,  IL 20692
Applicant Contact AMIR WALDMAN
Correspondent
Home Skinovations , Ltd.
Apolo Bldg.
Pob 533
Yokneam Illit,  IL 20692
Correspondent Contact AMIR WALDMAN
Regulation Number878.4810
Classification Product Code
OHT  
Date Received10/29/2010
Decision Date 11/10/2010
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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