The following data is part of a premarket notification filed by Iridex Corporation with the FDA for Iridex Trufocus Lio Premiere.
| Device ID | K170718 |
| 510k Number | K170718 |
| Device Name: | Iridex TruFocus LIO Premiere |
| Classification | Powered Laser Surgical Instrument |
| Applicant | Iridex Corporation 1212 Terra Bella Avenue Mountain View, CA 94043 -1824 |
| Contact | Gloria Dy |
| Correspondent | Gloria Dy Iridex Corporation 1212 Terra Bella Avenue Mountain View, CA 94043 -1824 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-03-09 |
| Decision Date | 2017-05-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00813125015695 | K170718 | 000 |
| 00813125015688 | K170718 | 000 |
| 00813125015671 | K170718 | 000 |
| 00813125015664 | K170718 | 000 |
| 00813125015657 | K170718 | 000 |