FDA 510(k)

雷射治療系統，型號Nyx plus、Grace plus、Nemesis、Ares

K 號：K211722 · 2022-02-25

申請人Canadian Pioneer Medical Technology Corporation

決定日期2022-02-25

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

Laser treatment system , models Nyx plus, Grace plus, Nemesis, Ares is the device name listed in this FDA 510(k) record. The listed applicant is Canadian Pioneer Medical Technology Corporation. It received FDA 510(k) clearance on 2022-02-25 under 510(k) number K211722. 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 Laser treatment system , models Nyx plus, Grace plus, Nemesis, Ares?

Laser treatment system , models Nyx plus, Grace plus, Nemesis, Ares is a medical device that received FDA 510(k) clearance on 2022-02-25. The listed applicant is Canadian Pioneer Medical Technology Corporation. The 510(k) number is K211722.

When did Laser treatment system , models Nyx plus, Grace plus, Nemesis, Ares receive FDA 510(k) clearance?

Laser treatment system , models Nyx plus, Grace plus, Nemesis, Ares received FDA 510(k) clearance on 2022-02-25, under 510(k) number K211722.

Who is the listed applicant for Laser treatment system , models Nyx plus, Grace plus, Nemesis, Ares?

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

What is the FDA product code for Laser treatment system , models Nyx plus, Grace plus, Nemesis, Ares?

The FDA product code for Laser treatment system , models Nyx plus, Grace plus, Nemesis, Ares is GEX. This falls under the Gastroenterology category.

其他以 Canadian Pioneer Medical Technology Corporation 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K212793雷射治療系統，型號：Hera，Armo K210033雷射治療系統，型號：NYX及Grace

相關器械（代碼：GEX）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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官方來源

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