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FDA 510(k)

VARILITE LASER SYSTEM

K-Number: K041930 · 2004-09-10

ApplicantIridex Corporation
Decision Date2004-09-10
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

VARILITE LASER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Iridex Corporation. It received FDA 510(k) clearance on 2004-09-10 under 510(k) number K041930. 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 VARILITE LASER SYSTEM?

VARILITE LASER SYSTEM is a medical device that received FDA 510(k) clearance on 2004-09-10. The listed applicant is Iridex Corporation. The 510(k) number is K041930.

When did VARILITE LASER SYSTEM receive FDA 510(k) clearance?

VARILITE LASER SYSTEM received FDA 510(k) clearance on 2004-09-10, under 510(k) number K041930.

Who is the listed applicant for VARILITE LASER SYSTEM?

The FDA 510(k) record lists Iridex Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VARILITE LASER SYSTEM?

The FDA product code for VARILITE LASER SYSTEM is GEX. This falls under the Gastroenterology category.

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Other records listing Iridex Corporation 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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