Cleared Special

Medi Lift Mask

K244048 · Ya-Man, Ltd. · Neurology
Jan 2025
Decision
16d
Days
Class 2
Risk

About This 510(k) Submission

K244048 is an FDA 510(k) clearance for the Medi Lift Mask, a Stimulator, Transcutaneous Electrical, Aesthetic Purposes (Class II — Special Controls, product code NFO), submitted by Ya-Man, Ltd. (Tokyo, JP). The FDA issued a Cleared decision on January 16, 2025, 16 days after receiving the submission on December 31, 2024. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5890.

Submission Details

510(k) Number K244048 FDA.gov
FDA Decision Cleared SESE
Date Received December 31, 2024
Decision Date January 16, 2025
Days to Decision 16 days
Submission Type Special
Review Panel Neurology (NE)
Summary Summary PDF

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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