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FDA 510(k)

CARBON DIOXIDE LASER SYSTEMS W/ARTHOGUIDE CO2 DEL.

K-Number: K910496 · 1991-05-06

ApplicantHeraeus Lasersonics, Inc.
Decision Date1991-05-06
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CARBON DIOXIDE LASER SYSTEMS W/ARTHOGUIDE CO2 DEL. 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 1991-05-06 under 510(k) number K910496. 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 CARBON DIOXIDE LASER SYSTEMS W/ARTHOGUIDE CO2 DEL.?

CARBON DIOXIDE LASER SYSTEMS W/ARTHOGUIDE CO2 DEL. is a medical device that received FDA 510(k) clearance on 1991-05-06. The listed applicant is Heraeus Lasersonics, Inc.. The 510(k) number is K910496.

When did CARBON DIOXIDE LASER SYSTEMS W/ARTHOGUIDE CO2 DEL. receive FDA 510(k) clearance?

CARBON DIOXIDE LASER SYSTEMS W/ARTHOGUIDE CO2 DEL. received FDA 510(k) clearance on 1991-05-06, under 510(k) number K910496.

Who is the listed applicant for CARBON DIOXIDE LASER SYSTEMS W/ARTHOGUIDE CO2 DEL.?

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 CARBON DIOXIDE LASER SYSTEMS W/ARTHOGUIDE CO2 DEL.?

The FDA product code for CARBON DIOXIDE LASER SYSTEMS W/ARTHOGUIDE CO2 DEL. 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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