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FDA 510(k)

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

K-Number: K252146 · 2025-12-23

ApplicantShenzhen Siken 3D Technology Development Co., Ltd.
Decision Date2025-12-23
Product CodeNFO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Multi-functional Facial Beauty Device ( SKB-1703,SKB-1803,SKB-1909, SKB-2003 SKB-2109,SKB-2129,SKB-2208PRO, SKB-2209) is a medical device manufactured by Shenzhen Siken 3D Technology Development Co., Ltd.. It received FDA 510(k) clearance on 2025-12-23 under approval number K252146. The device is classified under product code NFO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

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

Multi-functional Facial Beauty Device ( SKB-1703,SKB-1803,SKB-1909, SKB-2003 SKB-2109,SKB-2129,SKB-2208PRO, SKB-2209) is a medical device that received FDA 510(k) clearance on 2025-12-23. It is manufactured by Shenzhen Siken 3D Technology Development Co., Ltd.. The 510(k) number is K252146.

When was Multi-functional Facial Beauty Device ( SKB-1703,SKB-1803,SKB-1909, SKB-2003 SKB-2109,SKB-2129,SKB-2208PRO, SKB-2209) approved by the FDA?

Multi-functional Facial Beauty Device ( SKB-1703,SKB-1803,SKB-1909, SKB-2003 SKB-2109,SKB-2129,SKB-2208PRO, SKB-2209) received FDA 510(k) clearance on 2025-12-23, under approval number K252146.

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

Multi-functional Facial Beauty Device ( SKB-1703,SKB-1803,SKB-1909, SKB-2003 SKB-2109,SKB-2129,SKB-2208PRO, SKB-2209) is manufactured by Shenzhen Siken 3D Technology Development Co., Ltd..

What is the FDA product code for Multi-functional Facial Beauty Device ( SKB-1703,SKB-1803,SKB-1909, SKB-2003 SKB-2109,SKB-2129,SKB-2208PRO, SKB-2209)?

The FDA product code for Multi-functional Facial Beauty Device ( SKB-1703,SKB-1803,SKB-1909, SKB-2003 SKB-2109,SKB-2129,SKB-2208PRO, SKB-2209) is NFO.

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Related PubMed Literature

PMID: 42212181 Cybersecurity and Privacy Risks of Generative AI Mental-Health Chatbots: A Systematic Review and Regulatory Framework. Journal of multidisciplinary healthcare (2026) PMID: 42168293 Comparative in vitro and in vivo assessment of three experimental extracellular matrix meshes for soft tissue remodeling. Scientific reports (2026) PMID: 42127028 Proposed standards for prosthetic foot reuse and considerations for donation of used prosthetic feet to low-and middle-income countries. PLOS global public health (2026) PMID: 41153261 From Lab to Clinic: Artificial Intelligence with Spectroscopic Liquid Biopsies. Diagnostics (Basel, Switzerland) (2025)

Other Devices by Shenzhen Siken 3D Technology Development Co., Ltd.

K163470Galvanic Spa, Model: SKB-1405 K222710IPL Cooling Hair Removal Device K232845IPL Cooling Hair Removal Device K243040LED Light Therapy Mask (SKB-1818P,SKB-1918,SKB-1918P,SKB-1918PLUS,SKB-2318L,SKB-2318P,SKB-2318PRO,IN-FM002, SKB-2418) K252142Multi-functional Facial Beauty Device (SKB-1703,SKB-1803,SKB-1809, SKB-1909, SKB-2109,SKB-2129,SKB-2208PRO, SKB-2209)

Related Devices (Code: NFO)

K152199RejuvatoneMDTrophy Skin, Inc. K150826Nutra Face Lift Model PE8050Nutra Luxe MD, LLC K163550Pobling MIITY 2Habalan Med & Beauty Co.,Ltd K162652Smart Photon Micro-current Device, Model: EP-300Li-Tek Electronic Technology Corporation K171647BeneLife Premium Facial Treatment Pack, Model: QZ0701AInfinitus (China) Company , Ltd. K171588NuBODY Skin Toning DeviceCarol Cole Company Dba Nuface

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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