FDA 510(k)

多功能面部美容設備（SKB-1703、SKB-1803、SKB-1809、SKB-1909、SKB-2109、SKB-2129、SKB-2208PRO、SKB-2209）

K 號：K252142 · 2025-12-05

申請人Shenzhen Siken 3D Technology Development Co., Ltd.

決定日期2025-12-05

產品代碼OHS

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

Multi-functional Facial Beauty Device (SKB-1703,SKB-1803,SKB-1809, SKB-1909, 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 2025-12-05 under 510(k) number K252142. The device is classified under product code OHS. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Multi-functional Facial Beauty Device (SKB-1703,SKB-1803,SKB-1809, SKB-1909, SKB-2109,SKB-2129,SKB-2208PRO, SKB-2209)?

Multi-functional Facial Beauty Device (SKB-1703,SKB-1803,SKB-1809, SKB-1909, SKB-2109,SKB-2129,SKB-2208PRO, SKB-2209) is a medical device that received FDA 510(k) clearance on 2025-12-05. The listed applicant is Shenzhen Siken 3D Technology Development Co., Ltd.. The 510(k) number is K252142.

When did Multi-functional Facial Beauty Device (SKB-1703,SKB-1803,SKB-1809, SKB-1909, SKB-2109,SKB-2129,SKB-2208PRO, SKB-2209) receive FDA 510(k) clearance?

Multi-functional Facial Beauty Device (SKB-1703,SKB-1803,SKB-1809, SKB-1909, SKB-2109,SKB-2129,SKB-2208PRO, SKB-2209) received FDA 510(k) clearance on 2025-12-05, under 510(k) number K252142.

Who is the listed applicant for Multi-functional Facial Beauty Device (SKB-1703,SKB-1803,SKB-1809, SKB-1909, 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-1809, SKB-1909, SKB-2109,SKB-2129,SKB-2208PRO, SKB-2209)?

The FDA product code for Multi-functional Facial Beauty Device (SKB-1703,SKB-1803,SKB-1809, SKB-1909, SKB-2109,SKB-2129,SKB-2208PRO, SKB-2209) is OHS.

其他以 Shenzhen Siken 3D Technology Development Co., Ltd. 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K252146多功能面部美容設備（SKB-1703、SKB-1803、SKB-1909、SKB-2003、SKB-2109、SKB-2129、SKB-2208PRO、SKB-2209）K243040LED光療面膜（SKB-1818P、SKB-1918、SKB-1918P、SKB-1918PLUS、SKB-2318L、SKB-2318P、SKB-2318PRO、IN-FM002、SKB-2418）K232845IPL冷光除毛設備 K222710IPL冷光除毛設備 K163470鹹水電療機，型號：SKB-1405

相關器械（代碼：OHS）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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官方來源

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