Multi-functional Facial Beauty Device ( SKB-1703,SKB-1803,SKB-1909, SKB-2003 SKB-2109,SKB-2129,SKB-2208PRO, SKB-2209)— 510(k) K252146

Name: FDA 510(k) clearance K252146
Creator: U.S. Food and Drug Administration
Published: 2025-12-23

Substantially Equivalent

Shenzhen Siken 3D Technology Development Co., Ltd.

FDA 510(k) clearance K252146 for Multi-functional Facial Beauty Device ( SKB-1703,SKB-1803,SKB-1909, SKB-2003 SKB-2109,SKB-2129,SKB-2208PRO, SKB-2209), Substantially Equivalent on 2025-12-23. Applicant: Shenzhen Siken 3D Technology Development Co., Ltd.. Device class: 2.

Clearance details

Applicant: Shenzhen Siken 3D Technology Development Co., Ltd.
Product code: Code NFO
Device class: Class 2
Regulation: 21 CFR 882.5890
Advisory panel: Neurology
Date received: 2025-07-09
Decision date: 2025-12-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shenzhen, CN

Download summary PDF View on FDA.gov ↗

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