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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 K232424
Device Name CurrentBody Skin RF
Applicant
El Global Trade, Ltd.
6th Ha-Gavish St.
Netanya,  IL 4250706
Applicant Contact Sivan Fishman
Correspondent
El Global Trade, Ltd.
6th Ha-Gavish St.
Netanya,  IL 4250706
Correspondent Contact Sivan Fishman
Regulation Number878.4420
Classification Product Code
PAY  
Date Received08/11/2023
Decision Date 03/06/2024
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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