FDA 510(k)

SmoothSkin Pure Switch (SSC1)

K 號：K243362 · 2024-11-27

決定日期2024-11-27

產品代碼OHT

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

SmoothSkin Pure Switch (SSC1) is the device name listed in this FDA 510(k) record. The listed applicant is Cyden Limited. It received FDA 510(k) clearance on 2024-11-27 under 510(k) number K243362. The device is classified under product code OHT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the SmoothSkin Pure Switch (SSC1)?

SmoothSkin Pure Switch (SSC1) is a medical device that received FDA 510(k) clearance on 2024-11-27. The listed applicant is Cyden Limited. The 510(k) number is K243362.

When did SmoothSkin Pure Switch (SSC1) receive FDA 510(k) clearance?

SmoothSkin Pure Switch (SSC1) received FDA 510(k) clearance on 2024-11-27, under 510(k) number K243362.

Who is the listed applicant for SmoothSkin Pure Switch (SSC1)?

FDA 510(k) 記錄將 Cyden Limited 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for SmoothSkin Pure Switch (SSC1)?

The FDA product code for SmoothSkin Pure Switch (SSC1) is OHT.

其他以 Cyden Limited 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。

K261977布蘭恩光環9 (6042)K240587SmoothSkin Pure Unplugged (SSB3)K233782SmoothSkin Pure Adapt (SSG3)K230911布蘭恩皮膚 i.expert K213692SmoothSkin Pure Mini K211994布蘭德 Silk.expert Mini

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相關器械（代碼：OHT）

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。

K261977布蘭恩光環9 (6042)Cyden Limited K262524藍寶石冷光脫毛儀器（Ice 2.0、Ice 2.1、Ice 2.2、Ice 2.0B、Ice 2.1B、Ice 2.2B）ONE BEAUTY Technology Co., Ltd.K261705除毛設備（R3C16-G Pro, R3C16-V Pro）Shenzhen Jianchao Intelligent Technology Co., Ltd.K261325冰冷光療脫毛設備 (UI06S PR, UI06S PN, UI06S WH, UI06S PRU, UI06S PNU, UI06S WHU)Shenzhen Ulike Smart Electronics Co., Ltd.K260594IPL 髮毛去除器（FL-B505AG、FL-B505AP、FL-B505AM、FL-B507AG、FL-B507AP、FL-B507AM、FL-B508AG、FL-B508AP、FL-B508AM、FL-B509AG、FL-B509AP、FL-B509AM、FL-B510G、FL-B510P、FL-B510M、FL-B511G、FL-B511P、FL-B511M、FL-B512AG、FL-B512AP、FL-B512AM、FL-B513AG、FL-B513AP、FL-B513AM）Shenzhen Xiazhifeng Electronic Co., Ltd.K260742冰冷光療脫毛設備 (UI20S DB, UI20S RE, UI20S PW, UI20S GP, UI20S GR, UI20S BK)Shenzhen Ulike Smart Electronics Co., Ltd.

官方來源

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