FDA 510(k)

光子治療儀器（BL-10）

K 號：K243993 · 2025-03-13

申請人Xemis Medical Technology (Shenzhen) Co., Ltd.

決定日期2025-03-13

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

Photon Therapy Apparatus (BL-10) is the device name listed in this FDA 510(k) record. The listed applicant is Xemis Medical Technology (Shenzhen) Co., Ltd.. It received FDA 510(k) clearance on 2025-03-13 under 510(k) number K243993. 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 Photon Therapy Apparatus (BL-10)?

Photon Therapy Apparatus (BL-10) is a medical device that received FDA 510(k) clearance on 2025-03-13. The listed applicant is Xemis Medical Technology (Shenzhen) Co., Ltd.. The 510(k) number is K243993.

When did Photon Therapy Apparatus (BL-10) receive FDA 510(k) clearance?

Photon Therapy Apparatus (BL-10) received FDA 510(k) clearance on 2025-03-13, under 510(k) number K243993.

Who is the listed applicant for Photon Therapy Apparatus (BL-10)?

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

What is the FDA product code for Photon Therapy Apparatus (BL-10)?

The FDA product code for Photon Therapy Apparatus (BL-10) is GEX. This falls under the Gastroenterology category.

其他以 Xemis Medical Technology (Shenzhen) 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。

K244041超聲治療工作站（XMS-UET2）

相關器械（代碼：GEX）

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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