FDA 510(k)

reepot Nd; YAG 激光系統

K 號：K222555 · 2022-09-23

決定日期2022-09-23

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

reepot Nd; YAG laser system is the device name listed in this FDA 510(k) record. The listed applicant is Ilooda Co,., Ltd.. It received FDA 510(k) clearance on 2022-09-23 under 510(k) number K222555. 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 reepot Nd; YAG laser system?

reepot Nd; YAG laser system is a medical device that received FDA 510(k) clearance on 2022-09-23. The listed applicant is Ilooda Co,., Ltd.. The 510(k) number is K222555.

When did reepot Nd; YAG laser system receive FDA 510(k) clearance?

reepot Nd; YAG laser system received FDA 510(k) clearance on 2022-09-23, under 510(k) number K222555.

Who is the listed applicant for reepot Nd; YAG laser system?

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

What is the FDA product code for reepot Nd; YAG laser system?

The FDA product code for reepot Nd; YAG laser system is GEX. This falls under the Gastroenterology category.

其他以 Ilooda Co,., Ltd. 為申請人之記錄

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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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