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FDA 510(k)

OMNIGUIDE BEAMPATH FELS 25A CO2 LASER SYSTEM

K-Number: K093251 · 2009-10-29

ApplicantOmniguide, Inc.
Decision Date2009-10-29
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

OMNIGUIDE BEAMPATH FELS 25A CO2 LASER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Omniguide, Inc.. It received FDA 510(k) clearance on 2009-10-29 under 510(k) number K093251. 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 OMNIGUIDE BEAMPATH FELS 25A CO2 LASER SYSTEM?

OMNIGUIDE BEAMPATH FELS 25A CO2 LASER SYSTEM is a medical device that received FDA 510(k) clearance on 2009-10-29. The listed applicant is Omniguide, Inc.. The 510(k) number is K093251.

When did OMNIGUIDE BEAMPATH FELS 25A CO2 LASER SYSTEM receive FDA 510(k) clearance?

OMNIGUIDE BEAMPATH FELS 25A CO2 LASER SYSTEM received FDA 510(k) clearance on 2009-10-29, under 510(k) number K093251.

Who is the listed applicant for OMNIGUIDE BEAMPATH FELS 25A CO2 LASER SYSTEM?

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

What is the FDA product code for OMNIGUIDE BEAMPATH FELS 25A CO2 LASER SYSTEM?

The FDA product code for OMNIGUIDE BEAMPATH FELS 25A CO2 LASER SYSTEM 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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