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FDA 510(k)

多功能面部美容仪（SKB-1703，SKB-1803，SKB-1909，SKB-2003 SKB-2109，SKB-2129，SKB-2208PRO，SKB-2209）

K号: K252146 · 2025-12-23

申请人Shenzhen Siken 3D Technology Development Co., Ltd.
决定日期2025-12-23
产品代码NFO
咨询委员会NE 请注意，您提供的文本“NE”不足以进行翻译，因为它不是一个完整的句子或描述。请提供完整的医疗设备监管文本，以便我能够进行准确的翻译。
决定实质等同

器械摘要

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

常见问题

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. The listed applicant is Shenzhen Siken 3D Technology Development Co., Ltd.. The 510(k) number is K252146.

When did Multi-functional Facial Beauty Device ( SKB-1703,SKB-1803,SKB-1909, SKB-2003 SKB-2109,SKB-2129,SKB-2208PRO, SKB-2209) receive FDA 510(k) clearance?

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 510(k) number K252146.

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

The FDA 510(k) record lists Shenzhen Siken 3D Technology Development Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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.

相关临床试验

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

列明Shenzhen Siken 3D Technology Development Co., Ltd.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K252142多功能面部美容仪（SKB-1703，SKB-1803，SKB-1809，SKB-1909，SKB-2109，SKB-2129，SKB-2208PRO，SKB-2209）K243040LED光疗面罩（SKB-1818P，SKB-1918，SKB-1918P，SKB-1918PLUS，SKB-2318L，SKB-2318P，SKB-2318PRO，IN-FM002，SKB-2418）K232845IPL冷却脱毛设备K222710IPL冷却脱毛设备K163470Galvanic Spa，型号：SKB-1405

相关器械（代码：NFO）

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K261370LED光疗面罩（LED面部脉冲面罩（FAC06NA））Guangdong Newdermo Biotech Co., Ltd.K262861PureLift Pro MaxXtreem Pulse, LLCK260387SYNERJET PRO (SP-1003)；InPhiuse (SP-1003)；WOWJET (SP-1003)Hironic Co., Ltd.K253932FACEGYM Pro 设备（HD-109）Shenzhen Kaiyan Medical Equipment Co., Ltd.K260179VITA多功能头部刷（TB-2343F，TB-2442F）Touchbeauty Beauty & Health (Shenzhen) Co., Ltd.K260895优立克清零（YC10 BU）Guangxi Ulike Medical Technology Co., Ltd.

官方来源

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