K172645 is an FDA 510(k) clearance for the iLux Instrument, iLux Disposable. This device is classified as a Eyelid Thermal Pulsation System (Class II - Special Controls, product code ORZ).
Submitted by Tear Film Innovations, Inc. (San Diego, US). The FDA issued a Cleared decision on December 26, 2017, 116 days after receiving the submission on September 1, 2017.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.5200. Therapeutic Application Of Heat And Massage To The Eyelids..
| 510(k) Number | K172645 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 01, 2017 |
| Decision Date | December 26, 2017 |
| Days to Decision | 116 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | ORZ - Eyelid Thermal Pulsation System |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.5200 |
| Definition | Therapeutic Application Of Heat And Massage To The Eyelids. |