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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 the device name listed in this FDA 510(k) record. The listed applicant is Iridex Corporation. It received FDA 510(k) clearance on 2018-09-05 under 510(k) 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. The listed applicant is Iridex Corporation. The 510(k) number is K181662.

When did Iridex TruFocus LIO Premiere receive FDA 510(k) clearance?

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

Who is the listed applicant for Iridex TruFocus LIO Premiere?

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 Iridex TruFocus LIO Premiere?

The FDA product code for Iridex TruFocus LIO Premiere is GEX. This falls under the Gastroenterology category.

Other records listing Iridex Corporation as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K230228Iridex 532 Laser; Iridex 577 Laser; Iridex Laser (532 nm and 577 nm models)K223132Iridex PASCAL® 532, Iridex PASCAL® 577, Iridex PASCAL® (532nm and 577 nm models)K213592Iridex 810 LaserK202760Iridex 810 LaserK170718Iridex TruFocus LIO PremiereK162416IRIDEX Cyclo G6 Laser System, G-Probe Illuminate

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Related Devices (Code: GEX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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