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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
Home Skinovations Ltd.
Tabor Building, Shaar Yokneam
Yoqneam Illit,  IL 2069200
Applicant Contact Amit Goren
A. Stein - Regulatory Affairs Consulting Ltd.
20 Hata'as Str.
Suite 102
Kfar Saba,  IL 4442520
Correspondent Contact Amit Goren
Regulation Number890.5850
Classification Product Code
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