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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 2 of 5

Device	Model / Reference	Registries	Class	Status
Wireless Footswitch Power Adjust	31808	FDA UDI	Class II	Active
19.5G BriteLight™ Straight Endoprobe® Single	13900-1	FDA UDI	Class II	Active
Assy Final HS SLA IQ532 Standard Mount	65511	FDA UDI	Class II	Active
Assy Illumination Adapter Bright Star	15683	FDA UDI	Class II	Active
OtoProbe™ Long Angled Box of 6	14310	FDA UDI	Class II	Active
PASCAL Synthesis TwinStar (577nm/638nm)	PASCAL Synthesis 577/638	FDA UDI	Class II	Active
Head-Up-Display, HUD-1	Head-Up-Display, HUD-1	FDA UDI	Class I	Active
PASCAL Synthesis, 532nm	Synthesis SLC & ESF 532	FDA UDI	Class II	Active
TxCell for IQ532, H/S 900BM/BQ & CSO9900	70300	FDA UDI	Class II	Active
TxCell for IQ577, H/S 900BM/BQ & CSO9900	70295	FDA UDI	Class II	Active
25G Thumb Adjustable & Intuitive XR, EndoProbe® Box of 6	15907T	FDA UDI	Class II	Active
23-27G Angled 45° EndoProbe® Box of 6	14400	FDA UDI	Class II	Active
Cyclo G6 Laser Console	66245	FDA UDI	Class II	Active
G-Probe™ Single	11256-1	FDA UDI	Class II	Active
20G Angled 45° EndoProbe® Box of 6	10547	FDA UDI	Class II	Active
GLX NEO, Laser Console	33005	FDA UDI	Class II	Active
23G Thumb Adjustable & Intuitive XR, EndoProbe® Single	15906T-1	FDA UDI	Class II	Active
TruFocus LIO Premiere	TruFocus LIO Premiere, 810 LS	FDA UDI	Class II	Active
Safety Filter 532nm Zeiss Dovetail	30367	FDA UDI	Class II	Active
20-24G Angled 45° EndoProbe® Box of 6	14030	FDA UDI	Class II	Active
DioPexy w/ Tray	11454-1	FDA UDI	Class II	Active
G-Probe™ Illuminate Box of 6	16000	FDA UDI	Class II	Unknown
20G Thumb Adjustable & Intuitive EndoProbe® Single	14572T-1	FDA UDI	Class II	Active
TruFocus LIO Premiere	TruFocus LIO Premiere, 577	FDA UDI	Class II	Active
20G Angled LRE EndoProbe® Single	12934-1	FDA UDI	Class II	Active
20G Bayonet Straight EndoProbe® Box of 6	14420	FDA UDI	Class II	Active
19.5G BriteLight™ Angled 45° EndoProbe® Box of 6	13930	FDA UDI	Class II	Active
PASCAL Synthesis, 532nm	PASCAL Synthesis 532	FDA UDI	Class II	Active
Iridex 532 Laser	23000	FDA UDI	Class II	Active
PASCAL Synthesis, 577nm	PASCAL Synthesis 577	FDA UDI	Class II	Active
25G BriteLight™ EndoProbe® Single	14490-1	FDA UDI	Class II	Active
25G Straight Endoprobe® Single	13920-1	FDA UDI	Class II	Active
23-27G BriteLight™ Angled 45° EndoProbe® Box of 6	14545	FDA UDI	Class II	Active
Scanner, TxCEll Z130/577	70303	FDA UDI	Class II	Active
Scanner, TxCell CSO/577	70304	FDA UDI	Class II	Active
Assy Illumination Adapter B & L Stellaris	15775	FDA UDI	Class II	Active
Illuminating Bayonet EndoProbe® Handpiece	65728-1	FDA UDI	Class II	Active
20G Finger Adjustable & Intuitive XR, EndoProbe® Box of 6	15905F	FDA UDI	Class II	Active
SL Laser Console 220V	12730	FDA UDI	Class II	Active
PASCAL Synthesis, 577nm	PASCAL Synthesis 577	FDA UDI	Class II	Active
Iridex 577 Laser	24000	FDA UDI	Class II	Active
SLA IQ577 Zeiss 30	65622	FDA UDI	Class II	Active
23G Thumb Adjustable & Intuitive EndoProbe® Box of 6	14573T	FDA UDI	Class II	Active
FlexFiber™ 600, Single	15706-1	FDA UDI	Class II	Active
23G Finger Adjustable & Intuitive XR, EndoProbe® Single	15906F-1	FDA UDI	Class II	Active
FlexFiber™ 200, Box of 6	15702	FDA UDI	Class II	Active
TxCell for IQ532, Iridex Z 30 & CSO9800	70297	FDA UDI	Class II	Active
ASSY, Remote Control IQ Family	65777	FDA UDI	Class II	Active
PASCAL Synthesis, 577nm	PASCAL Synthesis 577- PA04	FDA UDI	Class II	Active
TruFocus LIO Premiere	TruFocus LIO Premiere, 810	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.