FDA 510(k)

ルメニス Y&R ラーザーシステム

K番号: K211979 · 2022-06-21

決定日2022-06-21

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

Lumenis Y&R Laser System is the device name listed in this FDA 510(k) record. The listed applicant is Lumenis, Inc.. It received FDA 510(k) clearance on 2022-06-21 under 510(k) number K211979. 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 Lumenis Y&R Laser System?

Lumenis Y&R Laser System is a medical device that received FDA 510(k) clearance on 2022-06-21. The listed applicant is Lumenis, Inc.. The 510(k) number is K211979.

When did Lumenis Y&R Laser System receive FDA 510(k) clearance?

Lumenis Y&R Laser System received FDA 510(k) clearance on 2022-06-21, under 510(k) number K211979.

Who is the listed applicant for Lumenis Y&R Laser System?

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

What is the FDA product code for Lumenis Y&R Laser System?

The FDA product code for Lumenis Y&R Laser System is GEX. This falls under the Gastroenterology category.

公式ソース

FDAデータベースで見る →

データはFDA Open APIから取得しています。最新かつ権威ある情報については、常に公式レコードを参照してください。

ルメニス Y&R ラーザーシステム

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）

公式ソース