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FDA 510(k)

CO2 SURGICAL LASER SYSTEM MODEL #IR106

K-Number: K882952 · 1988-11-02

ApplicantNiic U.S.A., Inc.
Decision Date1988-11-02
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CO2 SURGICAL LASER SYSTEM MODEL #IR106 is the device name listed in this FDA 510(k) record. The listed applicant is Niic U.S.A., Inc.. It received FDA 510(k) clearance on 1988-11-02 under 510(k) number K882952. 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 SURGICAL LASER SYSTEM MODEL #IR106?

CO2 SURGICAL LASER SYSTEM MODEL #IR106 is a medical device that received FDA 510(k) clearance on 1988-11-02. The listed applicant is Niic U.S.A., Inc.. The 510(k) number is K882952.

When did CO2 SURGICAL LASER SYSTEM MODEL #IR106 receive FDA 510(k) clearance?

CO2 SURGICAL LASER SYSTEM MODEL #IR106 received FDA 510(k) clearance on 1988-11-02, under 510(k) number K882952.

Who is the listed applicant for CO2 SURGICAL LASER SYSTEM MODEL #IR106?

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

What is the FDA product code for CO2 SURGICAL LASER SYSTEM MODEL #IR106?

The FDA product code for CO2 SURGICAL LASER SYSTEM MODEL #IR106 is GEX. This falls under the Gastroenterology category.

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Other records listing Niic U.S.A., Inc. as applicant

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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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