FDA 510(k)

醫用鈷釔纖維激光系統（UroFiber 60Q）

K 號：K242293 · 2024-11-19

決定日期2024-11-19

產品代碼GEX

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

Medical Thulium Fiber Laser Systems (UroFiber 60Q) is the device name listed in this FDA 510(k) record. The listed applicant is Rhein Laser Technologies Co., Ltd.. It received FDA 510(k) clearance on 2024-11-19 under 510(k) number K242293. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

常見問題

What is the Medical Thulium Fiber Laser Systems (UroFiber 60Q)?

Medical Thulium Fiber Laser Systems (UroFiber 60Q) is a medical device that received FDA 510(k) clearance on 2024-11-19. The listed applicant is Rhein Laser Technologies Co., Ltd.. The 510(k) number is K242293.

When did Medical Thulium Fiber Laser Systems (UroFiber 60Q) receive FDA 510(k) clearance?

Medical Thulium Fiber Laser Systems (UroFiber 60Q) received FDA 510(k) clearance on 2024-11-19, under 510(k) number K242293.

Who is the listed applicant for Medical Thulium Fiber Laser Systems (UroFiber 60Q)?

FDA 510(k) 記錄將 Rhein Laser Technologies Co., Ltd. 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Medical Thulium Fiber Laser Systems (UroFiber 60Q)?

The FDA product code for Medical Thulium Fiber Laser Systems (UroFiber 60Q) is GEX. This falls under the Gastroenterology category.

其他以 Rhein Laser Technologies Co., Ltd. 為申請人之記錄

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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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