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FDA 510(k)

ULTRALASE FLEXIBLE CO2 LASER WAVEGUIDE

K-Number: K112166 · 2011-10-21

ApplicantW and R Investments Dba Laser Engineering
Decision Date2011-10-21
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ULTRALASE FLEXIBLE CO2 LASER WAVEGUIDE is the device name listed in this FDA 510(k) record. The listed applicant is W and R Investments Dba Laser Engineering. It received FDA 510(k) clearance on 2011-10-21 under 510(k) number K112166. 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 2011-10-21. The listed applicant is W and R Investments Dba Laser Engineering. The 510(k) number is K112166.

When did ULTRALASE FLEXIBLE CO2 LASER WAVEGUIDE receive FDA 510(k) clearance?

ULTRALASE FLEXIBLE CO2 LASER WAVEGUIDE received FDA 510(k) clearance on 2011-10-21, under 510(k) number K112166.

Who is the listed applicant for ULTRALASE FLEXIBLE CO2 LASER WAVEGUIDE?

The FDA 510(k) record lists W and R Investments 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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Official Source

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

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