FDA 510(k)

CLARITY II 激光系統

K 號：K183566 · 2019-06-14

決定日期2019-06-14

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

CLARITY II Laser System is the device name listed in this FDA 510(k) record. The listed applicant is Lutronic Corporation. It received FDA 510(k) clearance on 2019-06-14 under 510(k) number K183566. 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 CLARITY II Laser System?

CLARITY II Laser System is a medical device that received FDA 510(k) clearance on 2019-06-14. The listed applicant is Lutronic Corporation. The 510(k) number is K183566.

When did CLARITY II Laser System receive FDA 510(k) clearance?

CLARITY II Laser System received FDA 510(k) clearance on 2019-06-14, under 510(k) number K183566.

Who is the listed applicant for CLARITY II Laser System?

The FDA 510(k) record lists Lutronic Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CLARITY II Laser System?

The FDA product code for CLARITY II Laser System is GEX. This falls under the Gastroenterology category.

其他以 Lutronic Corporation 為申請人之記錄

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