FDA 510(k)

無標記雷射

K 號：K242207 · 2025-03-07

決定日期2025-03-07

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

NOABLE LASER is the device name listed in this FDA 510(k) record. The listed applicant is Daeju Meditech Engineering Co., Ltd.. It received FDA 510(k) clearance on 2025-03-07 under 510(k) number K242207. 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 NOABLE LASER?

NOABLE LASER is a medical device that received FDA 510(k) clearance on 2025-03-07. The listed applicant is Daeju Meditech Engineering Co., Ltd.. The 510(k) number is K242207.

When did NOABLE LASER receive FDA 510(k) clearance?

NOABLE LASER received FDA 510(k) clearance on 2025-03-07, under 510(k) number K242207.

Who is the listed applicant for NOABLE LASER?

The FDA 510(k) record lists Daeju Meditech Engineering Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NOABLE LASER?

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

其他以 Daeju Meditech Engineering Co., Ltd. 為申請人之記錄

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官方來源

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