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FDA 510(k)

LUXAR ENDOGUIDE CO2 LASER WAVEGUIDE

K-Number: K896595 · 1990-01-09

ApplicantLuxar Corp.
Decision Date1990-01-09
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LUXAR ENDOGUIDE CO2 LASER WAVEGUIDE is the device name listed in this FDA 510(k) record. The listed applicant is Luxar Corp.. It received FDA 510(k) clearance on 1990-01-09 under 510(k) number K896595. 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 LUXAR ENDOGUIDE CO2 LASER WAVEGUIDE?

LUXAR ENDOGUIDE CO2 LASER WAVEGUIDE is a medical device that received FDA 510(k) clearance on 1990-01-09. The listed applicant is Luxar Corp.. The 510(k) number is K896595.

When did LUXAR ENDOGUIDE CO2 LASER WAVEGUIDE receive FDA 510(k) clearance?

LUXAR ENDOGUIDE CO2 LASER WAVEGUIDE received FDA 510(k) clearance on 1990-01-09, under 510(k) number K896595.

Who is the listed applicant for LUXAR ENDOGUIDE CO2 LASER WAVEGUIDE?

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

What is the FDA product code for LUXAR ENDOGUIDE CO2 LASER WAVEGUIDE?

The FDA product code for LUXAR ENDOGUIDE CO2 LASER WAVEGUIDE is GEX. This falls under the Gastroenterology category.

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Other records listing Luxar Corp. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K960475MODIFIED LUXAR LX-20 FAMILY CO2 LASER SYSTEMK953074MODIFIED LUXAR LX-20 FAMILY CO2 LASER SYSTEMK945888MODIFIED LUXAR LX-20 FAMILY C02 LASER SYSTEMK904068LUXAR MODEL LX-20 CO2 LASERK903079ENDOGUIDE (R), MICROGUIDE (TM), FLEXIGUIDE (TM)K900066FLEXIGUIDE(TM) CO2 LASER HOLLOW FLEXIBLE FIBER

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Related Devices (Code: GEX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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