FDA 510(k)

福麗斯

K 號：K242349 · 2024-09-09

決定日期2024-09-09

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

FoLix is the device name listed in this FDA 510(k) record. The listed applicant is Lumenis Be, Ltd.. It received FDA 510(k) clearance on 2024-09-09 under 510(k) number K242349. 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 FoLix?

FoLix is a medical device that received FDA 510(k) clearance on 2024-09-09. The listed applicant is Lumenis Be, Ltd.. The 510(k) number is K242349.

When did FoLix receive FDA 510(k) clearance?

FoLix received FDA 510(k) clearance on 2024-09-09, under 510(k) number K242349.

Who is the listed applicant for FoLix?

FDA 510(k) 記錄將 Lumenis Be, 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 FoLix?

The FDA product code for FoLix is GEX. This falls under the Gastroenterology category.

其他以 Lumenis Be, Ltd. 為申請人之記錄

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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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