Medical Device Manufacturer · US , Mountain View , CA

Iridex Corporation - FDA 510(k) Cleared Devices

9 submissions · 9 cleared · Since 2004

Total

Cleared

Denied

Iridex Corporation, is a worldwide leader in developing, manufacturing, and marketing innovative laser-based medical systems for the ophthalmology market. Founded in 1989, the company specializes in ophthalmic laser devices, delivery systems, and surgical instrumentation. Iridex maintains a manufacturing facility in Mountain View, California and serves customers globally through direct sales and approximately 60 independent distributors across over 100 countries.

The company has received 9 FDA 510(k) clearances from 9 total submissions between 2004 and 2023. Iridex's regulatory portfolio reflects deep expertise in ophthalmic laser systems for retinal and glaucoma treatment. The company's cleared devices span multiple therapeutic areas, including medical retina, glaucoma management, and vitreoretinal surgery applications.

Iridex's product portfolio includes laser systems for cyclophotocoagulation, transscleral laser therapy, and retinal photocoagulation. The company is known for its MicroPulse® technology, a patented pulsed laser approach, and the PASCAL® laser system for retinal treatment. Additional offerings include delivery devices, surgical probes, and consumable instrumentation designed for office-based and operating room use.

Please explore the full database to review specific device names, product codes, and individual 510(k) clearance dates for Iridex Corporation.

FDA 510(k) Regulatory Record - Iridex Corporation

9 devices

1-9 of 9

Iridex PASCAL® 532, Iridex PASCAL® 577, Iridex PASCAL® (532nm and 577 nm models)

K223132 · HQF

Ophthalmic · 37d