Cleared Traditional

Multi-functional Facial Beauty Device ( SKB-1703,SKB-1803,SKB-1909, SKB-2003 SKB-2109,SKB-2129,SKB-2208PRO, SKB-2209)

K252146 · Shenzhen Siken 3D Technology Development Co., Ltd. · Neurology
Dec 2025
Decision
167d
Days
Class 2
Risk

About This 510(k) Submission

K252146 is an FDA 510(k) clearance for the Multi-functional Facial Beauty Device ( SKB-1703,SKB-1803,SKB-1909, SKB-2003 SKB-2109,SKB-2129,SKB-2208PRO, SKB-2209), a Stimulator, Transcutaneous Electrical, Aesthetic Purposes (Class II — Special Controls, product code NFO), submitted by Shenzhen Siken 3D Technology Development Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on December 23, 2025, 167 days after receiving the submission on July 9, 2025. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5890.

Submission Details

510(k) Number K252146 FDA.gov
FDA Decision Cleared SESE
Date Received July 09, 2025
Decision Date December 23, 2025
Days to Decision 167 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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