FDA 510(k)

CO2雷射機（Monica-I，Monica-II）

K 號：K260974 · 2026-05-07

決定日期2026-05-07

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

CO2 Laser Machine (Monica-I,Monica-II) is the device name listed in this FDA 510(k) record. The listed applicant is Nanjing Bestview Laser S&T Co., Ltd.. It received FDA 510(k) clearance on 2026-05-07 under 510(k) number K260974. 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 CO2 Laser Machine (Monica-I,Monica-II)?

CO2 Laser Machine (Monica-I,Monica-II) is a medical device that received FDA 510(k) clearance on 2026-05-07. The listed applicant is Nanjing Bestview Laser S&T Co., Ltd.. The 510(k) number is K260974.

When did CO2 Laser Machine (Monica-I,Monica-II) receive FDA 510(k) clearance?

CO2 Laser Machine (Monica-I,Monica-II) received FDA 510(k) clearance on 2026-05-07, under 510(k) number K260974.

Who is the listed applicant for CO2 Laser Machine (Monica-I,Monica-II)?

The FDA 510(k) record lists Nanjing Bestview Laser S&T Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CO2 Laser Machine (Monica-I,Monica-II)?

The FDA product code for CO2 Laser Machine (Monica-I,Monica-II) is GEX. This falls under the Gastroenterology category.

其他以 Nanjing Bestview Laser S&T Co., Ltd. 為申請人之記錄

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官方來源

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