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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Transcutaneous Electrical, Aesthetic Purposes
510(k) Number K252621
Device Name DeepSkin (DEP100)
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 Number882.5890
Classification Product Code
NFO  
Date Received08/19/2025
Decision Date 05/08/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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