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FDA 510(k)

IRIDEX Cyclo G6 Laser System, G-Probe Illuminate

K-Number: K162416 · 2016-09-29

ApplicantIridex Corporation
Decision Date2016-09-29
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

IRIDEX Cyclo G6 Laser System, G-Probe Illuminate is a medical device manufactured by Iridex Corporation. It received FDA 510(k) clearance on 2016-09-29 under approval number K162416. 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 Cyclo G6 Laser System, G-Probe Illuminate?

IRIDEX Cyclo G6 Laser System, G-Probe Illuminate is a medical device that received FDA 510(k) clearance on 2016-09-29. It is manufactured by Iridex Corporation. The 510(k) number is K162416.

When was IRIDEX Cyclo G6 Laser System, G-Probe Illuminate approved by the FDA?

IRIDEX Cyclo G6 Laser System, G-Probe Illuminate received FDA 510(k) clearance on 2016-09-29, under approval number K162416.

What company makes IRIDEX Cyclo G6 Laser System, G-Probe Illuminate?

IRIDEX Cyclo G6 Laser System, G-Probe Illuminate is manufactured by Iridex Corporation.

What is the FDA product code for IRIDEX Cyclo G6 Laser System, G-Probe Illuminate?

The FDA product code for IRIDEX Cyclo G6 Laser System, G-Probe Illuminate is GEX. This falls under the Gastroenterology category.

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Other Devices by Iridex Corporation

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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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