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FDA 510(k)

醫用二極雷射系統（CHARISMA，REGAL）

K 號：K234004 · 2025-02-20

申請人Reveal Lasers , Ltd.
決定日期2025-02-20
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 (CHARISMA, REGAL) is the device name listed in this FDA 510(k) record. The listed applicant is Reveal Lasers , Ltd.. It received FDA 510(k) clearance on 2025-02-20 under 510(k) number K234004. 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 (CHARISMA, REGAL)?

Medical diode laser systems (CHARISMA, REGAL) is a medical device that received FDA 510(k) clearance on 2025-02-20. The listed applicant is Reveal Lasers , Ltd.. The 510(k) number is K234004.

When did Medical diode laser systems (CHARISMA, REGAL) receive FDA 510(k) clearance?

Medical diode laser systems (CHARISMA, REGAL) received FDA 510(k) clearance on 2025-02-20, under 510(k) number K234004.

Who is the listed applicant for Medical diode laser systems (CHARISMA, REGAL)?

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

What is the FDA product code for Medical diode laser systems (CHARISMA, REGAL)?

The FDA product code for Medical diode laser systems (CHARISMA, REGAL) is GEX. This falls under the Gastroenterology category.

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