FDA 510(k)

二極雷射 808nm

K 號：K192516 · 2019-12-10

申請人Beijing Superlaser Technology Co., Ltd.

決定日期2019-12-10

產品代碼GEX

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

Diode Laser 808nm is the device name listed in this FDA 510(k) record. The listed applicant is Beijing Superlaser Technology Co., Ltd.. It received FDA 510(k) clearance on 2019-12-10 under 510(k) number K192516. 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.

常見問題

What is the Diode Laser 808nm?

Diode Laser 808nm is a medical device that received FDA 510(k) clearance on 2019-12-10. The listed applicant is Beijing Superlaser Technology Co., Ltd.. The 510(k) number is K192516.

When did Diode Laser 808nm receive FDA 510(k) clearance?

Diode Laser 808nm received FDA 510(k) clearance on 2019-12-10, under 510(k) number K192516.

Who is the listed applicant for Diode Laser 808nm?

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

What is the FDA product code for Diode Laser 808nm?

The FDA product code for Diode Laser 808nm is GEX. This falls under the Gastroenterology category.

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