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FDA 510(k)

CO2 LASER COUPLER

K-Number: K983965 · 1998-12-22

ApplicantL.A.S.E.R., Inc.
Decision Date1998-12-22
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CO2 LASER COUPLER is the device name listed in this FDA 510(k) record. The listed applicant is L.A.S.E.R., Inc.. It received FDA 510(k) clearance on 1998-12-22 under 510(k) number K983965. 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 LASER COUPLER?

CO2 LASER COUPLER is a medical device that received FDA 510(k) clearance on 1998-12-22. The listed applicant is L.A.S.E.R., Inc.. The 510(k) number is K983965.

When did CO2 LASER COUPLER receive FDA 510(k) clearance?

CO2 LASER COUPLER received FDA 510(k) clearance on 1998-12-22, under 510(k) number K983965.

Who is the listed applicant for CO2 LASER COUPLER?

The FDA 510(k) record lists L.A.S.E.R., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CO2 LASER COUPLER?

The FDA product code for CO2 LASER COUPLER 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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