The following data is part of a premarket notification filed by Tear Film Innovations, Inc. with the FDA for Ilux Instrument, Ilux Disposable.
| Device ID | K172645 |
| 510k Number | K172645 |
| Device Name: | ILux Instrument, ILux Disposable |
| Classification | Eyelid Thermal Pulsation System |
| Applicant | Tear Film Innovations, Inc. 12625 High Bluff Drive, Suite 107 San Diego, CA 92130 |
| Contact | John Slate |
| Correspondent | John Slate Tear Film Innovations, Inc. 12625 High Bluff Drive, Suite 107 San Diego, CA 92130 |
| Product Code | ORZ |
| CFR Regulation Number | 886.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-01 |
| Decision Date | 2017-12-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00864461000418 | K172645 | 000 |
| 00864461000401 | K172645 | 000 |