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FDA 510(k)

醫用二極雷射系統（GBOX-6H、GBOX-10D、GBOX-12D、GBOX-15D、VELAS Pro-30B15D、VELAS II-6H、VELAS II-15D）

K 號：K241791 · 2025-03-19

申請人Gigaalaser Company , Ltd.
決定日期2025-03-19
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 Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D, VELAS II-6H, VELAS II-15D) is the device name listed in this FDA 510(k) record. The listed applicant is Gigaalaser Company , Ltd.. It received FDA 510(k) clearance on 2025-03-19 under 510(k) number K241791. 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 Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D, VELAS II-6H, VELAS II-15D)?

Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D, VELAS II-6H, VELAS II-15D) is a medical device that received FDA 510(k) clearance on 2025-03-19. The listed applicant is Gigaalaser Company , Ltd.. The 510(k) number is K241791.

When did Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D, VELAS II-6H, VELAS II-15D) receive FDA 510(k) clearance?

Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D, VELAS II-6H, VELAS II-15D) received FDA 510(k) clearance on 2025-03-19, under 510(k) number K241791.

Who is the listed applicant for Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D, VELAS II-6H, VELAS II-15D)?

The FDA 510(k) record lists Gigaalaser Company , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D, VELAS II-6H, VELAS II-15D)?

The FDA product code for Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D, VELAS II-6H, VELAS II-15D) is GEX. This falls under the Gastroenterology category.

相關臨床試驗

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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其他以 Gigaalaser Company , 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。

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官方來源

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