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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 Radiofrequency Coagulation Device For Wrinkle Reduction
510(k) Number K230013
Device Name Silk'n Titan Allways
Applicant
Silk'N Beauty , Ltd.
Tabor Bldg., Shaar Yokneam
Yokneam,  IL 2069200
Applicant Contact Amit Goren
Correspondent
A. Stein-Regulatory Affairs Consulting, Ltd.
18 Hata'As St.
Kfar Saba,  IL 444252018
Correspondent Contact Amit Goren
Regulation Number878.4420
Classification Product Code
PAY  
Subsequent Product Code
OHS  
Date Received01/03/2023
Decision Date 08/30/2023
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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