FDA 510(k)

二极管激光治疗系统

K号: K210168 · 2021-05-10

申请人Beijing Kes Biology Technology Co., Ltd.

决定日期2021-05-10

产品代码GEX

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决定实质等同

器械摘要

Diode Laser Therapy Systems is the device name listed in this FDA 510(k) record. The listed applicant is Beijing Kes Biology Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-05-10 under 510(k) number K210168. 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 Diode Laser Therapy Systems?

Diode Laser Therapy Systems is a medical device that received FDA 510(k) clearance on 2021-05-10. The listed applicant is Beijing Kes Biology Technology Co., Ltd.. The 510(k) number is K210168.

When did Diode Laser Therapy Systems receive FDA 510(k) clearance?

Diode Laser Therapy Systems received FDA 510(k) clearance on 2021-05-10, under 510(k) number K210168.

Who is the listed applicant for Diode Laser Therapy Systems?

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

What is the FDA product code for Diode Laser Therapy Systems?

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

列明Beijing Kes Biology 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。

K193477Nd: YAG 激光治疗系统

官方来源

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