FDA 510(k)

Alexandrite 和 Nd:YAG 激光模型 CANLASE 和 TORLASE

K 號：K222673 · 2022-11-17

申請人Canadian Pioneer Medical Technology Corporation (Cpmt Laser)

決定日期2022-11-17

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

Alexandrite and Nd:YAG Laser models CANLASE and TORLASE is the device name listed in this FDA 510(k) record. The listed applicant is Canadian Pioneer Medical Technology Corporation (Cpmt Laser). It received FDA 510(k) clearance on 2022-11-17 under 510(k) number K222673. 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 Alexandrite and Nd:YAG Laser models CANLASE and TORLASE?

Alexandrite and Nd:YAG Laser models CANLASE and TORLASE is a medical device that received FDA 510(k) clearance on 2022-11-17. The listed applicant is Canadian Pioneer Medical Technology Corporation (Cpmt Laser). The 510(k) number is K222673.

When did Alexandrite and Nd:YAG Laser models CANLASE and TORLASE receive FDA 510(k) clearance?

Alexandrite and Nd:YAG Laser models CANLASE and TORLASE received FDA 510(k) clearance on 2022-11-17, under 510(k) number K222673.

Who is the listed applicant for Alexandrite and Nd:YAG Laser models CANLASE and TORLASE?

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

What is the FDA product code for Alexandrite and Nd:YAG Laser models CANLASE and TORLASE?

The FDA product code for Alexandrite and Nd:YAG Laser models CANLASE and TORLASE is GEX. This falls under the Gastroenterology category.

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官方來源

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