FDA 510(k)

CO2 激光机 (Lume)

K号: K250465 · 2025-06-09

决定日期2025-06-09

产品代码GEX

咨询委员会SU 请注意，您提供的文本“SU”不足以进行翻译。请提供完整的描述性文本以便进行翻译。

决定实质等同

器械摘要

CO2 Laser Machine (Lume) 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 2025-06-09 under 510(k) number K250465. 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 (Lume)?

CO2 Laser Machine (Lume) is a medical device that received FDA 510(k) clearance on 2025-06-09. The listed applicant is Nanjing Bestview Laser S&T Co., Ltd.. The 510(k) number is K250465.

When did CO2 Laser Machine (Lume) receive FDA 510(k) clearance?

CO2 Laser Machine (Lume) received FDA 510(k) clearance on 2025-06-09, under 510(k) number K250465.

Who is the listed applicant for CO2 Laser Machine (Lume)?

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 (Lume)?

The FDA product code for CO2 Laser Machine (Lume) 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。

K260974CO2 激光机 (Monica-I, Monica-II)K260153Q-Switched Nd: YAG Laser System (Glamor Q)K251919钬激光系统（Deluxlase）K242440强脉冲光治疗系统（LK-PT）

官方来源

在 FDA 数据库中查看 →

数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。