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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 5 of 5| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Varilite Laser System | K041930 | FDA 510(k) | Class II | Active |
| Iridex 810 Laser | K202760 | FDA 510(k) | Class II | Active |
| Iris Medical Iq 810 Photocoagulator | K040209 | FDA 510(k) | Class II | Active |
| Txcell Scanning Laser Delivery System | K121475 | FDA 510(k) | Class II | Active |
| Iridex 810 Laser | K213592 | FDA 510(k) | Class II | Active |
| Iris Medical Oculight Gl/Glx Laser Systems | K031665 | FDA 510(k) | Class II | Active |
| Iridex Otoprobe Long And Short Angles, P/N 14310-1 And 14320-1 | K060905 | FDA 510(k) | Class II | Active |
| LIO Plus (810 nm) | 13152-H500 | EUDAMEDFDA UDI | Class I | Active |
| OMA (810 nm) | 13411 | EUDAMEDFDA UDI | Class I | Active |
| Pascal Lio | SA-06620 | EUDAMEDFDA UDI | Class I | Active |
| SLA (810 nm) | 12775 | EUDAMEDFDA UDI | Class I | Active |
| Eye Safety Filter, Fixed (577 nm) | 65470 | EUDAMEDFDA UDI | Class I | Active |
| Eye Safety Filter, Fixed (532 nm) | 30365 | EUDAMED | Class I | Active |
| LIO Plus (577 nm) | 65900-H500 | EUDAMEDFDA UDI | Class I | Active |
| Eye Safety Filter, Fixed (577nm) | 65551 | EUDAMEDFDA UDI | Class I | Active |
| LIO Plus Large Spot (810 nm) | 13153-H500 | EUDAMEDFDA UDI | Class I | Active |
| Eye Safety Two-Position, (577 nm) | 65472 | EUDAMEDFDA UDI | Class I | Active |
| Eye Safety Two-Position (532 nm) | 30494 | EUDAMEDFDA UDI | Class I | Active |
| Eye Safety Two-Position (532 nm) | 30493 | EUDAMEDFDA UDI | Class I | Active |
| SLA 50 µm (532 nm) | 31172-01 | EUDAMEDFDA UDI | Class I | Active |
| SLA Standard (577 nm) | 65512 | EUDAMEDFDA UDI | Class I | Active |
| SLA 50 µm (532 nm) | 31172-02 | EUDAMEDFDA UDI | Class I | Active |
| SLA 5 mm Large Spot (810 nm) | 13880-02 | EUDAMEDFDA UDI | Class I | Active |
| Eye Safety Filter, Fixed (532 nm) | 30364 | EUDAMEDFDA UDI | Class I | Active |
| Eye Safety Filter, Fixed (810 nm) | 10378 | EUDAMEDFDA UDI | Class I | Active |
| Pascal Lio | SA-06172 | EUDAMEDFDA UDI | Class I | Active |
| SLA EasyView™ (577 nm) | 65621 | EUDAMEDFDA UDI | Class I | Active |
| SLA Symphony 3 (532 nm & 810 nm) | 31122-02 | EUDAMED | Class I | Active |
| SLA EasyFit™ (532 nm) | 30898-Z3S | EUDAMEDFDA UDI | Class I | Active |
| SLA 50 µm (532 nm) | 31174-02 | EUDAMEDFDA UDI | Class I | Active |
| Pascal Lio | SA-06621 | EUDAMEDFDA UDI | Class I | Active |
| SLA 50 µm (532 nm) | 31174-01 | EUDAMEDFDA UDI | Class I | Active |
| OMA (810 nm) | 11671 | EUDAMEDFDA UDI | Class I | Active |
| Eye Safety Filter, Fixed (810 nm) | 13107 | EUDAMEDFDA UDI | Class I | Active |
| Eye Safety Filter, Fixed (532 nm) | 30366 | EUDAMEDFDA UDI | Class I | Active |
| SLA (532 nm) | 65505 | EUDAMEDFDA UDI | Class I | Active |
| Eye Safety Filter, Fixed (810 nm) | 11326 | EUDAMED | Class I | Active |
| Eye Safety Two-Position, (577 nm) | 65473 | EUDAMEDFDA UDI | Class I | Active |
| Eye Safety Filter, Fixed (577 nm) | 65471 | EUDAMEDFDA UDI | Class I | Active |
| LIO Plus (532 nm) | 65515-H500 | EUDAMEDFDA UDI | Class I | Active |
| OMA (810 nm) | 11672 | EUDAMEDFDA UDI | Class I | Active |
| SLA (577 nm) | 66274 | EUDAMEDFDA UDI | Class I | Active |
| Pascal Lio | SA-06171 | EUDAMEDFDA UDI | Class I | Active |
| Eye Safety Filter, Fixed (532 nm) | 30367 | EUDAMEDFDA UDI | Class I | Active |
| SLA (577 nm) | 65623 | EUDAMEDFDA UDI | Class I | Active |
| Eye Safety Filter, Fixed (810 nm) | 14080 | EUDAMEDFDA UDI | Class I | Active |
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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. |