Cleared Traditional

JMOON NouvelleSkin Facial Toning Device (M30U PR, M30U MW, M30U SG, M30U SK, M30U MP)

K243393 · Shenzhen Ulike Smart Electronics Co., Ltd. · Neurology
Feb 2025
Decision
95d
Days
Class 2
Risk

About This 510(k) Submission

K243393 is an FDA 510(k) clearance for the JMOON NouvelleSkin Facial Toning Device (M30U PR, M30U MW, M30U SG, M30U SK, M30U MP), a Stimulator, Transcutaneous Electrical, Aesthetic Purposes (Class II — Special Controls, product code NFO), submitted by Shenzhen Ulike Smart Electronics Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on February 3, 2025, 95 days after receiving the submission on October 31, 2024. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5890.

Submission Details

510(k) Number K243393 FDA.gov
FDA Decision Cleared SESE
Date Received October 31, 2024
Decision Date February 03, 2025
Days to Decision 95 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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