Cleared Traditional

Pr?ime DermaFacial (MicroT)

K243072 · EMA Aesthetics , Ltd. · Neurology
Apr 2025
Decision
186d
Days
Class 2
Risk

About This 510(k) Submission

K243072 is an FDA 510(k) clearance for the Pr?ime DermaFacial (MicroT), a Stimulator, Transcutaneous Electrical, Aesthetic Purposes (Class II — Special Controls, product code NFO), submitted by EMA Aesthetics , Ltd. (Dublin 2, IE). The FDA issued a Cleared decision on April 1, 2025, 186 days after receiving the submission on September 27, 2024. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5890.

Submission Details

510(k) Number K243072 FDA.gov
FDA Decision Cleared SESE
Date Received September 27, 2024
Decision Date April 01, 2025
Days to Decision 186 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement

Device Classification

Product Code NFO — Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.5890

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