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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 1 of 5

Device	Model / Reference	Registries	Class	Status
20G Aspirating Straight EndoProbe® Box of 6	14000	FDA UDI	Class II	Active
20G Thumb Adjustable & Intuitive EndoProbe® Box of 6	14572T	FDA UDI	Class II	Active
Scanner, TxCell Z30/532	70307	FDA UDI	Class II	Active
23G BriteLight™ EndoProbe® Single	14540-1	FDA UDI	Class II	Active
ML LIO+ w/Heine Headset Dual wavelength OMEGA 500	30903-H500	FDA UDI	Class II	Active
20G Aspirating Straight EndoProbe® Single	14000-1	FDA UDI	Class II	Active
20G Angled 45° EndoProbe® Single	10547-1	FDA UDI	Class II	Active
577nm Fixed Eye Safety Filter Leica/Wild	65470	FDA UDI	Class II	Active
23-27G Angled 45° EndoProbe® Single	14400-1	FDA UDI	Class II	Active
Scanner, TxCell Z120/577	70402	FDA UDI	Class II	Active
23G Finger Adjustable & Intuitive EndoProbe® Box of 6	14573F	FDA UDI	Class II	Active
PASCAL Synthesis, 532nm	Synthesis SLC & ESF 532	FDA UDI	Class II	Active
Iridex PASCAL 532	Iridex PASCAL 532	FDA UDI	Class II	Active
23G Thumb Adjustable & Intuitive EndoProbe® Single	14573T-1	FDA UDI	Class II	Active
Sla Iq577 Hs Bm/Bq	65512	FDA UDI	Class II	Active
Assy Illumination Adapter PHOTON	15653	FDA UDI	Class II	Active
19.5G BriteLight™ Straight EndoProbe® Box of 6	13900	FDA UDI	Class II	Active
25G Straight EndoProbe® Box of 6	13920	FDA UDI	Class II	Active
G-Probe™ RFID Single	15980-1	FDA UDI	Class II	Active
20G Fluted EndoProbe® Box of 6	11473	FDA UDI	Class II	Active
PASCAL Synthesis, 532nm	PASCAL Synthesis 532	FDA UDI	Class II	Active
20G Finger Adjustable & Intuitive EndoProbe® Box of 6	14572F	FDA UDI	Class II	Active
OcuLight TX Laser Console	32000-4	FDA UDI	Class II	Active
23G Straight RFID EndoProbe® Single	65716-1	FDA UDI	Class II	Active
IQ532XP Laser Console	66120	FDA UDI	Class II	Active
FlexFiber™ 400, Single	15704-1	FDA UDI	Class II	Active
PASCAL Synthesis, 577nm	Synthesis SLC & ESF 577	FDA UDI	Class II	Active
25G Thumb Adjustable & Intuitive EndoProbe® Single	14574T-1	FDA UDI	Class II	Active
FlexFiber™ 300, Box of 6	15703	FDA UDI	Class II	Active
SL Laser Console	12731	FDA UDI	Class II	Active
Scanner, TxCell HS BM/BQ577	70305	FDA UDI	Class II	Active
Safety Filter 810nm Zeiss Dovetail	10378	FDA UDI	Class II	Active
PASCAL Synthesis, 532nm	PASCAL Synthesis 532- PA04	FDA UDI	Class II	Active
25-27G BriteLight™ Angled 20° EndoProbe® Single	14560-1	FDA UDI	Class II	Active
Safety Filter 532 nm Topcon OMS 300/320	30366	FDA UDI	Class II	Active
Scanner, TxCell Z130/532	70308	FDA UDI	Class II	Active
25-30G Angled 45° EndoProbe® Box of 6	14120	FDA UDI	Class II	Active
23G Finger Adjustable & Intuitive EndoProbe® Single	14573F-1	FDA UDI	Class II	Active
PASCAL Synthesis, 577nm	PASCAL Synthesis 577	FDA UDI	Class II	Active
Scanner, TxCell HS BM/BQ 532	70310	FDA UDI	Class II	Active
IQ532 Laser Console	65500	FDA UDI	Class II	Active
20G Bayonet Angled 30° EndoProbe® Single	14410-1	FDA UDI	Class II	Active
FlexFiber™ 600, Box of 6	15706	FDA UDI	Class II	Active
23-27G BriteLight™ Angled 45° EndoProbe® Single	14545-1	FDA UDI	Class II	Active
23G BriteLight™ EndoProbe® Box of 6	14540	FDA UDI	Class II	Active
Iridex PASCAL 577	Iridex PASCAL 577	FDA UDI	Class II	Active
PASCAL Synthesis, 532nm	PASCAL Synthesis 532	FDA UDI	Class II	Active
SLA IQ532 Zeiss 30	65505	FDA UDI	Class II	Active
ASSY, HAAG STREIT 900 BM/BQ, 577nm	65621	FDA UDI	Class II	Active
19.5G BriteLight™ Angled 45° EndoProbe® Single	13930-1	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.