FDA 510(k)

Iridex 810 Laser

K-Number: K202760 · 2020-10-21

Decision Date2020-10-21

Product CodeHQF

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

Iridex 810 Laser is a medical device manufactured by Iridex Corporation. It received FDA 510(k) clearance on 2020-10-21 under approval number K202760. The device is classified under product code HQF. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Iridex 810 Laser?

Iridex 810 Laser is a medical device that received FDA 510(k) clearance on 2020-10-21. It is manufactured by Iridex Corporation. The 510(k) number is K202760.

When was Iridex 810 Laser approved by the FDA?

Iridex 810 Laser received FDA 510(k) clearance on 2020-10-21, under approval number K202760.

What company makes Iridex 810 Laser?

Iridex 810 Laser is manufactured by Iridex Corporation.

What is the FDA product code for Iridex 810 Laser?

The FDA product code for Iridex 810 Laser is HQF.

Other Devices by Iridex Corporation

K162416IRIDEX Cyclo G6 Laser System, G-Probe Illuminate K170718Iridex TruFocus LIO Premiere K181662Iridex TruFocus LIO Premiere K223132Iridex PASCAL® 532, Iridex PASCAL® 577, Iridex PASCAL® (532nm and 577 nm models) K213592Iridex 810 Laser K230228Iridex 532 Laser; Iridex 577 Laser; Iridex Laser (532 nm and 577 nm models)

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Related Devices (Code: HQF)

K153769R:GEN Laser SystemLutronic Corporation K152688LightLas Multi-Wavelength Medical Laser SystemLightmed Corporation K152603Green Laser Photocoagulator GYC-500Nidek Co., Ltd. K171488PSLT for PASCAL StreamlineTopcon Medical Laser Systems, Inc. K170067EasyretQuantel Medical K170302YELLOW LASER PHOTOCOAGULATOR YLC-500Nidek Co., Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.