FDA 510(k)

Nd: YAG 激光治疗系统

K号: K193477 · 2020-06-24

申请人Beijing Kes Biology Technology Co., Ltd.

决定日期2020-06-24

产品代码GEX

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决定实质等同

器械摘要

Nd: YAG 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 2020-06-24 under 510(k) number K193477. 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 Nd: YAG Laser Therapy Systems?

Nd: YAG Laser Therapy Systems is a medical device that received FDA 510(k) clearance on 2020-06-24. The listed applicant is Beijing Kes Biology Technology Co., Ltd.. The 510(k) number is K193477.

When did Nd: YAG Laser Therapy Systems receive FDA 510(k) clearance?

Nd: YAG Laser Therapy Systems received FDA 510(k) clearance on 2020-06-24, under 510(k) number K193477.

Who is the listed applicant for Nd: YAG 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 Nd: YAG Laser Therapy Systems?

The FDA product code for Nd: YAG 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

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K210168二极管激光治疗系统

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