Cleared Traditional

Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-70); Radiant Renewal Skincare Wand (HD-44)

K251034 · Shenzhen Nuon Medical Equipment Co., Ltd. · Neurology
Oct 2025
Decision
192d
Days
Class 2
Risk

About This 510(k) Submission

K251034 is an FDA 510(k) clearance for the Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-70); Radiant Renewal Skincare Wand (HD-44), a Stimulator, Transcutaneous Electrical, Aesthetic Purposes (Class II — Special Controls, product code NFO), submitted by Shenzhen Nuon Medical Equipment Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on October 12, 2025, 192 days after receiving the submission on April 3, 2025. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5890.

Submission Details

510(k) Number K251034 FDA.gov
FDA Decision Cleared SESE
Date Received April 03, 2025
Decision Date October 12, 2025
Days to Decision 192 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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