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FDA 510(k)

CO2 LASERS AND INFRAGUIDE DELIVERY SYSTEM

K-Number: K904423 · 1990-12-13

ApplicantHeraeus Lasersonics, Inc.
Decision Date1990-12-13
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CO2 LASERS AND INFRAGUIDE DELIVERY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Heraeus Lasersonics, Inc.. It received FDA 510(k) clearance on 1990-12-13 under 510(k) number K904423. 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 CO2 LASERS AND INFRAGUIDE DELIVERY SYSTEM?

CO2 LASERS AND INFRAGUIDE DELIVERY SYSTEM is a medical device that received FDA 510(k) clearance on 1990-12-13. The listed applicant is Heraeus Lasersonics, Inc.. The 510(k) number is K904423.

When did CO2 LASERS AND INFRAGUIDE DELIVERY SYSTEM receive FDA 510(k) clearance?

CO2 LASERS AND INFRAGUIDE DELIVERY SYSTEM received FDA 510(k) clearance on 1990-12-13, under 510(k) number K904423.

Who is the listed applicant for CO2 LASERS AND INFRAGUIDE DELIVERY SYSTEM?

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

What is the FDA product code for CO2 LASERS AND INFRAGUIDE DELIVERY SYSTEM?

The FDA product code for CO2 LASERS AND INFRAGUIDE DELIVERY SYSTEM is GEX. This falls under the Gastroenterology category.

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Other records listing Heraeus Lasersonics, Inc. as applicant

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Related Devices (Code: GEX)

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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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