Cleared Traditional

Medi Lift PLUS

K220198 · Ya-Man, Ltd. · Neurology
Jun 2023
Decision
520d
Days
Class 2
Risk

About This 510(k) Submission

K220198 is an FDA 510(k) clearance for the Medi Lift PLUS, a Stimulator, Transcutaneous Electrical, Aesthetic Purposes (Class II — Special Controls, product code NFO), submitted by Ya-Man, Ltd. (Koto-Ku, JP). The FDA issued a Cleared decision on June 28, 2023, 520 days after receiving the submission on January 24, 2022. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5890.

Submission Details

510(k) Number K220198 FDA.gov
FDA Decision Cleared SESE
Date Received January 24, 2022
Decision Date June 28, 2023
Days to Decision 520 days
Submission Type Traditional
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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