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FDA 510(k)

IRIDERM, MODEL APEX 800

K-Number: K992298 · 1999-12-09

ApplicantIridex Corp
Decision Date1999-12-09
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

IRIDERM, MODEL APEX 800 is the device name listed in this FDA 510(k) record. The listed applicant is Iridex Corp. It received FDA 510(k) clearance on 1999-12-09 under 510(k) number K992298. 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 IRIDERM, MODEL APEX 800?

IRIDERM, MODEL APEX 800 is a medical device that received FDA 510(k) clearance on 1999-12-09. The listed applicant is Iridex Corp. The 510(k) number is K992298.

When did IRIDERM, MODEL APEX 800 receive FDA 510(k) clearance?

IRIDERM, MODEL APEX 800 received FDA 510(k) clearance on 1999-12-09, under 510(k) number K992298.

Who is the listed applicant for IRIDERM, MODEL APEX 800?

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 IRIDERM, MODEL APEX 800?

The FDA product code for IRIDERM, MODEL APEX 800 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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