FDA 510(k)

レジェナルエースレーザーシステム

K番号: K233344 · 2024-05-28

決定日2024-05-28

製品コードGEX

諮問委員会SU （以下のテキストは翻訳されていません。） Policy: medical-regulatory-v1

決定大幅同等

医療機器の概要

Regenalase Laser System is the device name listed in this FDA 510(k) record. The listed applicant is Ipg Medical. It received FDA 510(k) clearance on 2024-05-28 under 510(k) number K233344. 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.

よくある質問

What is the Regenalase Laser System?

Regenalase Laser System is a medical device that received FDA 510(k) clearance on 2024-05-28. The listed applicant is Ipg Medical. The 510(k) number is K233344.

When did Regenalase Laser System receive FDA 510(k) clearance?

Regenalase Laser System received FDA 510(k) clearance on 2024-05-28, under 510(k) number K233344.

Who is the listed applicant for Regenalase Laser System?

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

What is the FDA product code for Regenalase Laser System?

The FDA product code for Regenalase Laser System is GEX. This falls under the Gastroenterology category.

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レジェナルエースレーザーシステム

医療機器の概要

よくある質問

関連する臨床試験

関連機器（コード：GEX）

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