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Sign in to claim this brandIridex 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.com/company/iridex
- facebook.com/IRIDEX
- [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 4 of 5| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| MicroPulse P3 Device Single | 15522-1 | FDA UDI | Class II | Active |
| 20G Bayonet Straight EndoProbe® Single | 14420-1 | FDA UDI | Class II | Active |
| OcuLight GL Laser Console | 33004-1 | FDA UDI | Class II | Active |
| 25G Finger Adjustable & Intuitive, EndoProbe® Box of 6 | 14574F | FDA UDI | Class II | Active |
| FlexFiber™ 300, Single | 15703-1 | FDA UDI | Class II | Active |
| 20G Fluted EndoProbe® Single | 11473-1 | FDA UDI | Class II | Active |
| MicroPulse® P3 Device Single | 15522-1 | FDA UDI | Class II | Active |
| TX Laser Console | 32000-1 | FDA UDI | Class II | Active |
| IQ532 Laser Console | 65500-08 | FDA UDI | Class II | Active |
| Safety Filter 810nm Leica/Wild Dovetail | 11175 | FDA UDI | Class II | Active |
| PASCAL Synthesis TwinStar (577nm/638nm) | PASCAL Synthesis 577/638 | FDA UDI | Class II | Active |
| PASCAL Synthesis, 577nm | Synthesis SLC & ESF 577 | FDA UDI | Class II | Active |
| 23G Finger Adjustable & Intuitive XR, EndoProbe® Box of 6 | 15906F | FDA UDI | Class II | Active |
| PASCAL Synthesis, 532nm | Synthesis SLC & ESF 532 | FDA UDI | Class II | Active |
| OtoProbe™ Short Angled Single | 14320-1 | FDA UDI | Class II | Active |
| Cyclo G6 Laser Console | 66245-1 | FDA UDI | Class II | Active |
| 25G Finger Adjustable & Intuitive, EndoProbe® Single | 14574F-1 | FDA UDI | Class II | Active |
| OtoProbe™ Long Angled Single | 14310-1 | FDA UDI | Class II | Active |
| Footswitch Half Assembly | 12167 | FDA UDI | Class II | Active |
| TxCell for IQ577, Iridex Z 30 & CSO980 | 70292 | FDA UDI | Class II | Active |
| 20G Straight EndoProbe® Single | 10562-1 | FDA UDI | Class II | Active |
| 25-27G BriteLight™ Angled 20° EndoProbe® Box of 6 | 14560 | FDA UDI | Class II | Active |
| 23G Angled 45° RFID EndoProbe® Box of 6 | 65698 | FDA UDI | Class II | Active |
| SLA 5 mm Large Spot (810 nm) | 13880-01 | EUDAMEDFDA UDI | Class I | Active |
| Eye Safety Filter, Fixed (532 nm) | 31260 | EUDAMEDFDA UDI | Class I | Active |
| SLA (810 nm) | 10842 | EUDAMEDFDA UDI | Class I | Active |
| LIO Plus (532 nm & 810 nm) | 30903-H500 | EUDAMEDFDA UDI | Class I | Active |
| Eye Safety Filter, Fixed (810 nm) | 11175 | EUDAMEDFDA UDI | Class I | Active |
| Eye Safety Two-Position, (532 nm) | 65475 | EUDAMEDFDA UDI | Class I | Active |
| Eye Safety Two-Position, (532 nm) | 65474 | EUDAMEDFDA UDI | Class I | Active |
| SLA Standard (532 nm) | 65511 | EUDAMEDFDA UDI | Class I | Active |
| SLA EasyFit™ (532 nm) | 30898-Z30 | EUDAMEDFDA UDI | Class I | Active |
| Eye Safety Filter, Fixed (532 nm) | 30775 | EUDAMEDFDA UDI | Class I | Active |
| SLA (577 nm) | 65622 | EUDAMEDFDA UDI | Class I | Active |
| SLA EasyView™ (532 nm) | 65504 | EUDAMEDFDA UDI | Class I | Active |
| Iridex Oculight Tx | K062369 | FDA 510(k) | Class II | Active |
| Iridex TruFocus LIO Premiere | K181662 | FDA 510(k) | Class II | Active |
| Oculight Gl/Glx | K050562 | FDA 510(k) | Class II | Active |
| IRIDEX Cyclo G6 Laser System, G-Probe Illuminate | K162416 | FDA 510(k) | Class II | Active |
| Oculight Gl With The Dermatology Handpiece | K982031 | FDA 510(k) | Class II | Active |
| Iridex PASCAL® 532, Iridex PASCAL® 577, Iridex PASCAL® (532nm and 577 nm models) | K223132 | FDA 510(k) | Class II | Active |
| Iridex Wireless Footswitch | K062074 | FDA 510(k) | Class II | Active |
| Oculight Sl/Slx | K020374 | FDA 510(k) | Class II | Active |
| IRIDEX CycloG6 Laser System, MicroPulse P3 Drive, G-Probe(RFID) | K143154 | FDA 510(k) | Class II | Active |
| Iridex 532 Laser; Iridex 577 Laser; Iridex Laser (532 nm and 577 nm models) | K230228 | FDA 510(k) | Class II | Active |
| Family Of Iris Medical Endoprobe Handpieces | K022228 | FDA 510(k) | Class II | Active |
| Apex 800 Laser System, Model Apex 800 | K020849 | FDA 510(k) | Class II | Active |
| Iridex TruFocus LIO Premiere | K170718 | FDA 510(k) | Class II | Active |
| Famili Of Iridex Iq Laser Systems | K071687 | FDA 510(k) | Class II | Active |
| Iriderm, Model Apex 800 | K992298 | FDA 510(k) | Class II | Active |
Related Companies
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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. |