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FDA 510(k)

Iridex TruFocus LIO Premiere

K-Number: K181662 · 2018-09-05

ApplicantIridex Corporation
Decision Date2018-09-05
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Iridex TruFocus LIO Premiere is a medical device manufactured by Iridex Corporation. It received FDA 510(k) clearance on 2018-09-05 under approval number K181662. 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 Iridex TruFocus LIO Premiere?

Iridex TruFocus LIO Premiere is a medical device that received FDA 510(k) clearance on 2018-09-05. It is manufactured by Iridex Corporation. The 510(k) number is K181662.

When was Iridex TruFocus LIO Premiere approved by the FDA?

Iridex TruFocus LIO Premiere received FDA 510(k) clearance on 2018-09-05, under approval number K181662.

What company makes Iridex TruFocus LIO Premiere?

Iridex TruFocus LIO Premiere is manufactured by Iridex Corporation.

What is the FDA product code for Iridex TruFocus LIO Premiere?

The FDA product code for Iridex TruFocus LIO Premiere 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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