FDA 510(k) Applications for Medical Device Product Code "ORZ"
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K240512 | Novoxel Ltd. | Tixel i (TXLI0001) | 11/04/2024 |
| K231084 | Sight Sciences, Inc. | TearCare MGX System | 12/27/2023 |
| K242786 | Sight Sciences, Inc. | TearCare MGX System | 04/15/2025 |
| K213045 | Sight Sciences, Inc. | TearCare System | 12/21/2021 |
| K172645 | Tear Film Innovations, Inc. | iLux Instrument, iLux Disposable | 12/26/2017 |
| K200400 | Tear Film Innovations, Inc. | Systane iLux2 | 05/21/2020 |
| K192623 | TearScience Inc. | LipiFlow Thermal Pulsation System | 10/22/2019 |
| DEN100017 | TEARSCIENCE, INC. | LIPFLOW THERMAL PULSATION SYSTEM (FORMERLY MANUAL MINI SYSTEM) | 06/28/2011 |
| K112704 | TEARSCIENCE, INC. | LIPIFLOW THERMAL PULSATION SYSTEM | 12/19/2011 |
| K133127 | TEARSCIENCE, INC. | LIPIFLOW THERMAL PULSATION SYSTEM | 12/23/2013 |
| K161357 | TEARSCIENCE, INC. | LipiFlow Thermal Pulsation System | 11/04/2016 |
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