Milpitas, CA, US · 3 510(k) clearances · 8 PMAs · 2 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| OOE | Ophthalmic Femtosecond Laser | Class II | Ophthalmic | 3 | 2023-04-12 |
| Date | PMA # | Trade name | Type | Code | Device name | Specialty |
|---|---|---|---|---|---|---|
| 2024-08-09 | P930016-S067 | iDESIGN Refractive Studio, STAR S4 IR Excimer Laser System | Normal 180 Day Track No User Fee | LZS | Excimer Laser System | Unknown |
| 2024-07-01 | P930016-S065 | STAR S4 IR Excimer Laser | Real-Time Process | LZS | Excimer Laser System | Unknown |
| 2024-03-22 | P930016-S066 | iDesign Refractive Studio | Real-Time Process | LZS | Excimer Laser System | Unknown |
| 2024-03-21 | P930016-S064 | iDesign Refractive Studio (iDesign/G301) | Real-Time Process | LZS | Excimer Laser System | Unknown |
| 2023-10-16 | P930016-S063 | iDesign Refractive Studio | 30-Day Notice | LZS | Excimer Laser System | Unknown |
| 2021-02-26 | P930016-S062 | iDesign Advanced WaveScan Studio, STAR Excimer Laser System | Normal 180 Day Track No User Fee | LZS | Excimer Laser System | Unknown |
| 2020-02-14 | P930016-S061 | iDESIGN Refractive Studio | Real-Time Process | LZS | Excimer Laser System | Unknown |
| 2020-01-28 | P930016-S060 | iDESIGN Refractive Studio | Real-Time Process | LZS | Excimer Laser System | Unknown |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2021-10-21 | Class II | Ongoing | Z-0444-2022 | Catalys Precision Laser System, Models: Catalys-U (United States), Catalys-I (International), Catalys-C (China); and Cat… | — | Aberrometer and precision laser systems are affected by a remote code execution vulnerability existing when the Microsoft Windows Print Spooler service is enabl… |
| 2021-10-21 | Class II | Ongoing | Z-0443-2022 | iDesign, Model - G300: System AWS (International), System AWS (China), Advanced WaveScan Studio (United States); iDesign… | — | Aberrometer and precision laser systems are affected by a remote code execution vulnerability existing when the Microsoft Windows Print Spooler service is enabl… |