Cleared Traditional

JOVS Electric Stimulation Beauty Device (JE2)

K250227 · Shenzhen Qianyu Technology Co., Ltd. · Neurology
Oct 2025
Decision
263d
Days
Class 2
Risk

About This 510(k) Submission

K250227 is an FDA 510(k) clearance for the JOVS Electric Stimulation Beauty Device (JE2), a Stimulator, Transcutaneous Electrical, Aesthetic Purposes (Class II — Special Controls, product code NFO), submitted by Shenzhen Qianyu Technology Co., Ltd. (Shenzhen City, CN). The FDA issued a Cleared decision on October 17, 2025, 263 days after receiving the submission on January 27, 2025. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5890.

Submission Details

510(k) Number K250227 FDA.gov
FDA Decision Cleared SESE
Date Received January 27, 2025
Decision Date October 17, 2025
Days to Decision 263 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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