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Iridex Corporation

United States·US-MF-000029814

Last updated September 17, 2026

About

Leading ophthalmic laser manufacturer offering advanced ophthalmic medical devices designed for precise eye treatments and superior patient outcomes.

From the manufacturer's own website. Source

Information

Country: United States
Address: 1212, Terra Bella Avenue, Mountain View, United States
Website: www.iridex.com
LinkedIn: linkedin.com/company/iridex
Facebook: facebook.com/IRIDEX
Email: [email protected]
Phone: +1 650-605-8727
PRRC Contact: Bill Hyatt
EUDAMED SRN: US-MF-000029814
FDA FEI Number: 2939653
DUNS Number: —

Catalogue (246)

Page 3 of 5

Device	Model / Reference	Registries	Class	Status
LIO+810 w/Heine Headset IR LIO w/ Omega 500 Head set	13152-H500	FDA UDI	Class II	Active
20G Bayonet Angled 30° EndoProbe® Box of 6	14410	FDA UDI	Class II	Active
23G Thumb Adjustable & Intuitive XR, EndoProbe® Box of 6	15906T	FDA UDI	Class II	Active
G-Probe™ Box of 6	11256	FDA UDI	Class II	Active
IQ577 Laser Console	65600-08	FDA UDI	Class II	Active
G-Probe™ RFID Box of 6	15980	FDA UDI	Class II	Active
Zeiss Dovetail 577nm ESF	65471	FDA UDI	Class II	Active
25G Finger Adjustable & Intuitive XR, EndoProbe® Box of 6	15907F	FDA UDI	Class II	Active
FlexFiber™ 200, Single	15702-1	FDA UDI	Class II	Active
23G Straight EndoProbe® Single	14390-1	FDA UDI	Class II	Active
G-Probe™ Illuminate Single	16000-1	FDA UDI	Class II	Unknown
20G Straight EndoProbe® Box of 6	10562	FDA UDI	Class II	Active
G-Probe™ Short Handle Single	12044-1	FDA UDI	Class II	Active
23G Straight EndoProbe® Box of 6	14390	FDA UDI	Class II	Active
Assy Footswitch Packaged	60684	FDA UDI	Class II	Active
20G Finger Adjustable & Intuitive EndoProbe® Single	14572F-1	FDA UDI	Class II	Active
20G Angled LRE EndoProbe® Box of 6	12934	FDA UDI	Class II	Active
RFID LIO+ 532nm w/Heine Omega Headband	65515-H500	FDA UDI	Class II	Active
23G Angled 45° RFID EndoProbe® Single	65698-1	FDA UDI	Class II	Active
SLx Laser Console	13030-220	FDA UDI	Class II	Active
25G BriteLight™ EndoProbe® Box of 6	14490	FDA UDI	Class II	Active
Safety Filter 532nm Leica/Wild Dovetail M650/M690	30364	FDA UDI	Class II	Active
25G Thumb Adjustable & Intuitive XR, EndoProbe® Single	15907T-1	FDA UDI	Class II	Active
IRIDEX 810 Laser	22000	FDA UDI	Class II	Active
G-Probe™ Short Handle Box of 6	12044	FDA UDI	Class II	Active
MicroPulse® P3 Device Box of 6	15522	FDA UDI	Class II	Active
20-24G Angled 45° EndoProbe® Single	14030-1	FDA UDI	Class II	Active
IQ577 Laser Console	65600-01	FDA UDI	Class II	Active
OtoProbe™ Short Angled Box of 6	14320	FDA UDI	Class II	Active
LIO 577nm w/HEINE OMEGA 500	65900-H500	FDA UDI	Class II	Active
25G Finger Adjustable & Intuitive XR, EndoProbe® Single	15907F-1	FDA UDI	Class II	Active
Scanner, TxCell CSO/532	70309	FDA UDI	Class II	Active
FlexFiber™ 400, Box of 6	15704	FDA UDI	Class II	Active
25-30G Angled 45° EndoProbe® Single	14120-1	FDA UDI	Class II	Active
25G Thumb Adjustable & Intuitive EndoProbe® Box of 6	14574T	FDA UDI	Class II	Active
GL NEO Laser Console	33004	FDA UDI	Class II	Active
Scanner, TxCEll Z30/577	70302	FDA UDI	Class II	Active
OcuLight SLx Tri-Mode Console 115V	13030	FDA UDI	Class II	Active
G-Probe™ Illuminate Single	16200-1	FDA UDI	Class II	Active
TruFocus LIO Premiere	TruFocus LIO Premiere, 532	FDA UDI	Class II	Active
G-Probe™ Illuminate Box of 6	16200	FDA UDI	Class II	Active
TruFocus LIO Premiere	TruFocus LIO Premiere, 532/810	FDA UDI	Class II	Active
20G Finger Adjustable & Intuitive XR, EndoProbe® Single	15905F-1	FDA UDI	Class II	Active
Scanner, TxCell Z120/532	70403	FDA UDI	Class II	Active
PASCAL Synthesis, 577nm	Synthesis SLC & ESF 577	FDA UDI	Class II	Active
IQ810 Laser Console	60001-1	FDA UDI	Class II	Active
Wireless Footswitch Non-Power Adjust	31824	FDA UDI	Class II	Active
23G Straight RFID EndoProbe® Box of 6	65716	FDA UDI	Class II	Active
Assembly, Footswitch Iq Series	60638	FDA UDI	Class II	Active
MicroPulse P3 Device Box of 6	15522	FDA UDI	Class II	Active

Related Companies

Authorised Representatives

Emergo Europe B.V. NL

Importers

Not available yet.

Notified Bodies

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Authorities

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FDA Recalls (1)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Feb 27, 2018	Z-1075-2018	—	terminated	It was discovered that the laser energy was not going where intended to put it, resulting in focal cataracts and iris burns.