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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 K243072
Device Name Préime DermaFacial (MicroT)
Applicant
EMA Aesthetics , Ltd.
Palmerston House
Fenian St.
Dublin 2,  IE D02 WD37
Applicant Contact Alice Daniels
Correspondent
EMA Aesthetics , Ltd.
Palmerston House
Fenian St.
Dublin 2,  IE D02 WD37
Correspondent Contact Alice Daniels
Regulation Number882.5890
Classification Product Code
NFO  
Date Received09/27/2024
Decision Date 04/01/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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