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FDA 510(k)

超激光柔軟CO2激光導波管

K 號：K211761 · 2021-07-30

申請人W & R Investments, LLC Dba Laser Engineering
決定日期2021-07-30
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

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.

常見問題

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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