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Sign in to claim this brandOptiMedica Corp.
US
Last updated September 17, 2026
Information
- Country
- US
- Address
- 510 Cottonwood Dr, Milpitas, CA, 95035
- Website
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- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 3005675890
- DUNS Number
- —
Catalogue (14)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Liquid Optics Interface | LOI-12 | FDA UDI | Class II | Active |
| Liquid Optics Interface | LOI-BP | FDA UDI | Class II | Active |
| Catalys System | 0160-9500 | FDA UDI | Class II | Active |
| Liquid Optics Interface | LOI-12-BP | FDA UDI | Class II | Active |
| Catalys System | CATALYS-U | FDA UDI | Class II | Active |
| Liquid Optics Interface | LOI | FDA UDI | Class II | Active |
| Catalys Precision Laser System | K121091 | FDA 510(k) | Class II | Active |
| Optimedica Catalys Precision Laser System | K141079 | FDA 510(k) | Class II | Active |
| Catalys Precision Laser System | K161455 | FDA 510(k) | Class II | Active |
| Pascal Streamline Photocoagulator | K100019 | FDA 510(k) | Class II | Active |
| Pascal Synthesis Delivery System | K081744 | FDA 510(k) | Class II | Active |
| Optimedica Laser Indirect Ophthalmoscope | K062336 | FDA 510(k) | Class II | Active |
| Optimedica Catalys Precision Laser System | K113479 | FDA 510(k) | Class II | Active |
| Pascal Photocoagulator, Pascal-Us | K091666 | FDA 510(k) | Class II | Active |
Related Companies
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FDA Recalls (2)
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 20, 2015 | Z-1683-2015 | — | terminated | Software anomaly on OptiMedica CATALYS System version 3.00.05 that may result in incorrect parameters provided for cataract incision surgeon templates and both eyes have the same parameters. |
| Dec 20, 2013 | Z-0649-2014 | — | terminated | Potential for unexpected heating of the transformer mounting bolt located within the system chassis and the subsequent melting of a non-slip computer shelf mat, which may manifest an odor and visible smoke. |