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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 K250361
Device Name SmartAppGuidedTM MicroCurrent Face-Lift Pen 6 in 1
Applicant
Geske Beauty Tech GmbH
Leipziger Platz 18
Berlin,  DE 10117
Applicant Contact Natalia Reshetnikova
Correspondent
Geske Beauty Tech GmbH
Leipziger Platz 18
Berlin,  DE 10117
Correspondent Contact Natalia Reshetnikova
Regulation Number882.5890
Classification Product Code
NFO  
Date Received02/10/2025
Decision Date 05/23/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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