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FDA 510(k)

SMARTRION COMBI/亞歷山大紅寶石 & 長脈衝Nd:YAG雷射

K 號：K222485 · 2023-03-29

申請人Ids, Limited
決定日期2023-03-29
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

SMARTRION COMBI/Alexandrite & Long Pulsed Nd:YAG Laser is the device name listed in this FDA 510(k) record. The listed applicant is Ids, Limited. It received FDA 510(k) clearance on 2023-03-29 under 510(k) number K222485. 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 SMARTRION COMBI/Alexandrite & Long Pulsed Nd:YAG Laser?

SMARTRION COMBI/Alexandrite & Long Pulsed Nd:YAG Laser is a medical device that received FDA 510(k) clearance on 2023-03-29. The listed applicant is Ids, Limited. The 510(k) number is K222485.

When did SMARTRION COMBI/Alexandrite & Long Pulsed Nd:YAG Laser receive FDA 510(k) clearance?

SMARTRION COMBI/Alexandrite & Long Pulsed Nd:YAG Laser received FDA 510(k) clearance on 2023-03-29, under 510(k) number K222485.

Who is the listed applicant for SMARTRION COMBI/Alexandrite & Long Pulsed Nd:YAG Laser?

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

What is the FDA product code for SMARTRION COMBI/Alexandrite & Long Pulsed Nd:YAG Laser?

The FDA product code for SMARTRION COMBI/Alexandrite & Long Pulsed Nd:YAG Laser is GEX. This falls under the Gastroenterology category.

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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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官方來源

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