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Iridex 810 Laser

FDA 510(k)

Class II (US FDA 510(k))

510(k) K213592

by Iridex Corporation

Identifiers

510(k) Number
K213592 FDA 510(k)
FDA Product Code
HQF FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 886.4390 FDA 510(k)
Regulation Number
886.4390 FDA 510(k)
Advisory Committee
Ophthalmic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Iridex 810 Laser is an ophthalmic laser device designed for precise eye treatments. Classified as a Class II medical device, it employs laser diodes operating at 810 nm for therapeutic applications and a 650 nm aiming beam for alignment. This device is intended for use in retinal and anterior segment procedures, delivering controlled energy via an optical fiber delivery system.

The system consists of a laser console with integrated footswitch, imaging optics, power supply, and embedded software. It is supplied as a reusable medical device, requiring proper sterilization and maintenance per manufacturer guidelines. The device is regulated under FDA 510(k) clearance (K213592) and adheres to regulatory standards for ophthalmic laser safety. No MRI compatibility or single-use specifications are indicated.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Ophthalmic Lasers, Laser Probes, Ophthalmology Equipment ... - IRIDEX, PDF IQ 810TM Laser System - IRIDEX, Iridex 810 Laser by Iridex Corporation | FDA 510 (k) Summary, IRIDEX® IQ 810™ Infrared Laser - ophthalmologyweb.com

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Iridex Corporation

Sources (1)

  • FDA 510(k) K213592 24 fields · synced Sep 20, 2026