FDA 510(k)

CO2 激光机 (Monica-I, Monica-II)

K号: K260974 · 2026-05-07

决定日期2026-05-07

产品代码GEX

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决定实质等同

器械摘要

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.

常见问题

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.

列明Nanjing Bestview Laser S&T Co., Ltd.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K260153Q-Switched Nd: YAG Laser System (Glamor Q)K251919钬激光系统（Deluxlase）K250465CO2 激光机 (Lume)K242440强脉冲光治疗系统（LK-PT）

官方来源

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