The following data is part of a premarket notification filed by Tear Film Innovations, Inc. with the FDA for Systane Ilux2.
| Device ID | K200400 |
| 510k Number | K200400 |
| Device Name: | Systane ILux2 |
| Classification | Eyelid Thermal Pulsation System |
| Applicant | Tear Film Innovations, Inc. 5924 Balfour Court, Suite 100 Carlsbad, CA 92008 |
| Contact | Neal Hartman |
| Correspondent | Neal Hartman Tear Film Innovations, Inc. 5924 Balfour Court, Suite 100 Carlsbad, CA 92008 |
| Product Code | ORZ |
| CFR Regulation Number | 886.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-02-18 |
| Decision Date | 2020-05-21 |