FDA 510(k)

二极管激光治疗系统

K号: K212978 · 2021-11-10

决定日期2021-11-10

产品代码GEX

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决定实质等同

器械摘要

Diode laser therapy system is the device name listed in this FDA 510(k) record. The listed applicant is Beijing Unt Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-11-10 under 510(k) number K212978. 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 system?

Diode laser therapy system is a medical device that received FDA 510(k) clearance on 2021-11-10. The listed applicant is Beijing Unt Technology Co., Ltd.. The 510(k) number is K212978.

When did Diode laser therapy system receive FDA 510(k) clearance?

Diode laser therapy system received FDA 510(k) clearance on 2021-11-10, under 510(k) number K212978.

Who is the listed applicant for Diode laser therapy system?

The FDA 510(k) record lists Beijing Unt 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 system?

The FDA product code for Diode laser therapy system is GEX. This falls under the Gastroenterology category.

列明Beijing Unt 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。

K232532Nd:Yag 激光治疗系统

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