Iridex Corporation
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 9
- Inspections
- 5
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-1075-2018 | Class II | Iridex TruFocus LIO Premiere" Laser Indirect Ophthalmoscope ( LIO ) The LIO is a headmounted i | February 27, 2018 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K230228 | Iridex 532 Laser; Iridex 577 Laser; Iridex Laser (532 nm and 577 nm models) | February 23, 2023 |
| K223132 | Iridex PASCAL® 532, Iridex PASCAL® 577, Iridex PASCAL® (532nm and 577 nm models) | November 9, 2022 |
| K213592 | Iridex 810 Laser | March 23, 2022 |
| K202760 | Iridex 810 Laser | October 21, 2020 |
| K181662 | Iridex TruFocus LIO Premiere | September 5, 2018 |
| K170718 | Iridex TruFocus LIO Premiere | May 3, 2017 |
| K162416 | IRIDEX Cyclo G6 Laser System, G-Probe Illuminate | September 29, 2016 |
| K143154 | IRIDEX CycloG6 Laser System, MicroPulse P3 Drive, G-Probe(RFID) | January 2, 2015 |
| K041930 | VARILITE LASER SYSTEM | September 10, 2004 |