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FDA 510(k)

OCULIGHT GL/GLX

K-Number: K050562 · 2005-04-14

ApplicantIridex Corp
Decision Date2005-04-14
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

OCULIGHT GL/GLX is the device name listed in this FDA 510(k) record. The listed applicant is Iridex Corp. It received FDA 510(k) clearance on 2005-04-14 under 510(k) number K050562. 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 OCULIGHT GL/GLX?

OCULIGHT GL/GLX is a medical device that received FDA 510(k) clearance on 2005-04-14. The listed applicant is Iridex Corp. The 510(k) number is K050562.

When did OCULIGHT GL/GLX receive FDA 510(k) clearance?

OCULIGHT GL/GLX received FDA 510(k) clearance on 2005-04-14, under 510(k) number K050562.

Who is the listed applicant for OCULIGHT GL/GLX?

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

What is the FDA product code for OCULIGHT GL/GLX?

The FDA product code for OCULIGHT GL/GLX is GEX. This falls under the Gastroenterology category.

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Other records listing Iridex Corp 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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