The following data is part of a premarket notification filed by Iridex Corporation with the FDA for Iridex Trufocus Lio Premiere.
| Device ID | K181662 |
| 510k Number | K181662 |
| Device Name: | Iridex TruFocus LIO Premiere |
| Classification | Powered Laser Surgical Instrument |
| Applicant | Iridex Corporation 1212 Terra Bella Avenue Mountain View, CA 94043 |
| Contact | Edward J. Sinclair |
| Correspondent | Edward J. Sinclair Iridex Corporation 1212 Terra Bella Avenue Mountain View, CA 94043 -1824 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-06-25 |
| Decision Date | 2018-09-05 |