Cleared Traditional

Sunny Plus (Sunny)

K251649 · ShenB Co., Ltd. · Neurology
Sep 2025
Decision
112d
Days
Class 2
Risk

About This 510(k) Submission

K251649 is an FDA 510(k) clearance for the Sunny Plus (Sunny), a Stimulator, Transcutaneous Electrical, Aesthetic Purposes (Class II — Special Controls, product code NFO), submitted by ShenB Co., Ltd. (Seoul, KR). The FDA issued a Cleared decision on September 18, 2025, 112 days after receiving the submission on May 29, 2025. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5890.

Submission Details

510(k) Number K251649 FDA.gov
FDA Decision Cleared SESE
Date Received May 29, 2025
Decision Date September 18, 2025
Days to Decision 112 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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