FDA 510(k)

UltraLase フレキシブル CO2 レーザー波導

K番号: K211761 · 2021-07-30

申請者W & R Investments, LLC Dba Laser Engineering

決定日2021-07-30

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

UltraLase Flexible CO2 Laser Waveguide is the device name listed in this FDA 510(k) record. The listed applicant is W & R Investments, LLC Dba Laser Engineering. It received FDA 510(k) clearance on 2021-07-30 under 510(k) number K211761. 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 UltraLase Flexible CO2 Laser Waveguide?

UltraLase Flexible CO2 Laser Waveguide is a medical device that received FDA 510(k) clearance on 2021-07-30. The listed applicant is W & R Investments, LLC Dba Laser Engineering. The 510(k) number is K211761.

When did UltraLase Flexible CO2 Laser Waveguide receive FDA 510(k) clearance?

UltraLase Flexible CO2 Laser Waveguide received FDA 510(k) clearance on 2021-07-30, under 510(k) number K211761.

Who is the listed applicant for UltraLase Flexible CO2 Laser Waveguide?

The FDA 510(k) record lists W & R Investments, LLC Dba Laser Engineering as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for UltraLase Flexible CO2 Laser Waveguide?

The FDA product code for UltraLase Flexible CO2 Laser Waveguide is GEX. This falls under the Gastroenterology category.

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UltraLase フレキシブル CO2 レーザー波導

医療機器の概要

よくある質問

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関連機器（コード：GEX）

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