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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 K250341
Device Name Sensilift Pro (ST300XXYYZZZ)
Applicant
El Global Trade, Ltd.
Gibore Israel 13
Netanya,  IL 42407
Applicant Contact Stephanie Khoury
Correspondent
El Global Trade, Ltd.
Gibore Israel 13
Netanya,  IL 42407
Correspondent Contact Stephanie Khoury
Regulation Number878.4420
Classification Product Code
PAY  
Date Received02/06/2025
Decision Date 01/06/2026
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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