FDA 510(k)

CO2 激光治疗系统

K号: K192528 · 2019-12-03

申请人Shangdong Huamei Technology Co., Ltd.

决定日期2019-12-03

产品代码GEX

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决定实质等同

器械摘要

CO2 Laser Therapy System is the device name listed in this FDA 510(k) record. The listed applicant is Shangdong Huamei Technology Co., Ltd.. It received FDA 510(k) clearance on 2019-12-03 under 510(k) number K192528. 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 Therapy System?

CO2 Laser Therapy System is a medical device that received FDA 510(k) clearance on 2019-12-03. The listed applicant is Shangdong Huamei Technology Co., Ltd.. The 510(k) number is K192528.

When did CO2 Laser Therapy System receive FDA 510(k) clearance?

CO2 Laser Therapy System received FDA 510(k) clearance on 2019-12-03, under 510(k) number K192528.

Who is the listed applicant for CO2 Laser Therapy System?

The FDA 510(k) record lists Shangdong Huamei Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CO2 Laser Therapy System?

The FDA product code for CO2 Laser Therapy System is GEX. This falls under the Gastroenterology category.

列明Shangdong Huamei Technology 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。

K230816强脉冲光治疗系统 K202758Nd: YAG 激光治疗系统 HM-YL900 K200751光动力疗法（PDT）设备 K192521强脉冲光治疗系统

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