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 has 9 FDA 510(k) cleared medical devices. Based in Mountain View, US.

Last cleared in 2023. Active since 2004. Primary specialty: Ophthalmic.

Browse the FDA 510(k) cleared devices submitted by Iridex Corporation Filter by specialty or product code using the sidebar.

FDA 510(k) cleared devices by Iridex Corporation

9 devices

1-9 of 9

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

Iridex TruFocus LIO Premiere

K181662 · GEX

Ophthalmic · 72d

Cleared May 03, 2017

Iridex TruFocus LIO Premiere

K170718 · GEX

General & Plastic Surgery · 55d

Cleared Sep 29, 2016

IRIDEX Cyclo G6 Laser System, G-Probe Illuminate

K162416 · GEX

General & Plastic Surgery · 30d

Cleared Jan 02, 2015

IRIDEX CycloG6 Laser System, MicroPulse P3 Drive, G-Probe(RFID)

K143154 · GEX

General & Plastic Surgery · 60d

Cleared Sep 10, 2004

VARILITE LASER SYSTEM

K041930 · GEX

General & Plastic Surgery · 53d

Iridex Corporation - FDA 510(k) Cleared Devices

FDA 510(k) cleared devices by Iridex Corporation

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