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FDA 510(k)

UltraLase Flexible CO2 Laser Waveguide

K-Number: K211761 · 2021-07-30

ApplicantW & R Investments, LLC Dba Laser Engineering
Decision Date2021-07-30
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

UltraLase Flexible CO2 Laser Waveguide is a medical device manufactured by W & R Investments, LLC Dba Laser Engineering. It received FDA 510(k) clearance on 2021-07-30 under approval 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.

Frequently Asked Questions

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. It is manufactured by W & R Investments, LLC Dba Laser Engineering. The 510(k) number is K211761.

When was UltraLase Flexible CO2 Laser Waveguide approved by the FDA?

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

What company makes UltraLase Flexible CO2 Laser Waveguide?

UltraLase Flexible CO2 Laser Waveguide is manufactured by W & R Investments, LLC Dba Laser Engineering.

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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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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