FDA 510(k)

帕拉斯308/311固態紫外線雷射系統

K 號：K191501 · 2020-01-03

決定日期2020-01-03

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

PALLAS 308/311 Solid-State UV Laser System is the device name listed in this FDA 510(k) record. The listed applicant is Laseroptek Co., Ltd.. It received FDA 510(k) clearance on 2020-01-03 under 510(k) number K191501. 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 PALLAS 308/311 Solid-State UV Laser System?

PALLAS 308/311 Solid-State UV Laser System is a medical device that received FDA 510(k) clearance on 2020-01-03. The listed applicant is Laseroptek Co., Ltd.. The 510(k) number is K191501.

When did PALLAS 308/311 Solid-State UV Laser System receive FDA 510(k) clearance?

PALLAS 308/311 Solid-State UV Laser System received FDA 510(k) clearance on 2020-01-03, under 510(k) number K191501.

Who is the listed applicant for PALLAS 308/311 Solid-State UV Laser System?

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

What is the FDA product code for PALLAS 308/311 Solid-State UV Laser System?

The FDA product code for PALLAS 308/311 Solid-State UV Laser System is GEX. This falls under the Gastroenterology category.

其他以 Laseroptek Co., Ltd. 為申請人之記錄

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