FDA 510(k)

Co2雷射系統，型號：PureLase 及 VanLase

K 號：K232133 · 2024-04-16

申請人Cpmt Laser (Canadian Pioneer Medical Technology Corporation)

決定日期2024-04-16

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

Co2 Laser System, Models: PureLase And VanLase is the device name listed in this FDA 510(k) record. The listed applicant is Cpmt Laser (Canadian Pioneer Medical Technology Corporation). It received FDA 510(k) clearance on 2024-04-16 under 510(k) number K232133. 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 Co2 Laser System, Models: PureLase And VanLase?

Co2 Laser System, Models: PureLase And VanLase is a medical device that received FDA 510(k) clearance on 2024-04-16. The listed applicant is Cpmt Laser (Canadian Pioneer Medical Technology Corporation). The 510(k) number is K232133.

When did Co2 Laser System, Models: PureLase And VanLase receive FDA 510(k) clearance?

Co2 Laser System, Models: PureLase And VanLase received FDA 510(k) clearance on 2024-04-16, under 510(k) number K232133.

Who is the listed applicant for Co2 Laser System, Models: PureLase And VanLase?

The FDA 510(k) record lists Cpmt Laser (Canadian Pioneer Medical Technology Corporation) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Co2 Laser System, Models: PureLase And VanLase?

The FDA product code for Co2 Laser System, Models: PureLase And VanLase is GEX. This falls under the Gastroenterology category.

其他以 Cpmt Laser (Canadian Pioneer Medical Technology Corporation) 為申請人之記錄

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