FDA 510(k)

ND:YAG 激光器

K 號：K193464 · 2020-04-13

申請人Beijing Superlaser Technology Co., Ltd.

決定日期2020-04-13

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

ND:YAG Laser 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 2020-04-13 under 510(k) number K193464. 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 ND:YAG Laser?

ND:YAG Laser is a medical device that received FDA 510(k) clearance on 2020-04-13. The listed applicant is Beijing Superlaser Technology Co., Ltd.. The 510(k) number is K193464.

When did ND:YAG Laser receive FDA 510(k) clearance?

ND:YAG Laser received FDA 510(k) clearance on 2020-04-13, under 510(k) number K193464.

Who is the listed applicant for ND:YAG Laser?

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 ND:YAG Laser?

The FDA product code for ND:YAG Laser is GEX. This falls under the Gastroenterology category.

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