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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Muscle, Powered, For Muscle Conditioning
510(k) Number K180279
Device Name Silk'n MODEL H5003 device
Applicant
Home Skinovations , Ltd.
Tabor Bldg., Shaar Yokneam
Yokneam,  IL 2069200
Applicant Contact Amit Goren
Correspondent
A. Stein - Regulatory Affairs Consulting , Ltd.
20 Hata'As St. , Suite 102
K Far Saba,  IL 4442520
Correspondent Contact Amit Goren
Regulation Number890.5850
Classification Product Code
NGX  
Date Received01/31/2018
Decision Date 05/09/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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