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FDA 510(k)

AZURYT MODEL CTL 1401, CO2 SURGICAL LASER SYSTEM

K-Number: K062248 · 2006-08-17

ApplicantNorth American Clinical Lasers, Ltd.
Decision Date2006-08-17
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

AZURYT MODEL CTL 1401, CO2 SURGICAL LASER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is North American Clinical Lasers, Ltd.. It received FDA 510(k) clearance on 2006-08-17 under 510(k) number K062248. 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 AZURYT MODEL CTL 1401, CO2 SURGICAL LASER SYSTEM?

AZURYT MODEL CTL 1401, CO2 SURGICAL LASER SYSTEM is a medical device that received FDA 510(k) clearance on 2006-08-17. The listed applicant is North American Clinical Lasers, Ltd.. The 510(k) number is K062248.

When did AZURYT MODEL CTL 1401, CO2 SURGICAL LASER SYSTEM receive FDA 510(k) clearance?

AZURYT MODEL CTL 1401, CO2 SURGICAL LASER SYSTEM received FDA 510(k) clearance on 2006-08-17, under 510(k) number K062248.

Who is the listed applicant for AZURYT MODEL CTL 1401, CO2 SURGICAL LASER SYSTEM?

The FDA 510(k) record lists North American Clinical Lasers, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AZURYT MODEL CTL 1401, CO2 SURGICAL LASER SYSTEM?

The FDA product code for AZURYT MODEL CTL 1401, CO2 SURGICAL LASER SYSTEM is GEX. This falls under the Gastroenterology category.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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