Cleared Traditional

Jmoon FlexGlow Light Therapy Device (JD20U SP, JD20U SG)

K251825 · Shenzhen Ulike Smart Electronics Co., Ltd. · General & Plastic Surgery
Oct 2025
Decision
110d
Days
Class 2
Risk

About This 510(k) Submission

K251825 is an FDA 510(k) clearance for the Jmoon FlexGlow Light Therapy Device (JD20U SP, JD20U SG), a Light Based Over The Counter Wrinkle Reduction (Class II — Special Controls, product code OHS), submitted by Shenzhen Ulike Smart Electronics Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on October 1, 2025, 110 days after receiving the submission on June 13, 2025. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4810.

Submission Details

510(k) Number K251825 FDA.gov
FDA Decision Cleared SESE
Date Received June 13, 2025
Decision Date October 01, 2025
Days to Decision 110 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code OHS — Light Based Over The Counter Wrinkle Reduction
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.4810
Definition Use Of Light Based Treatment To Reduce Wrinkles On The Body In General Or Specific Anatomical Locations Depending On The Information Provided.

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