ORZ
12 FDA 510(k) clearances · Product code
172 daysmedian time to decision
269 days90th percentile
12clearances measured
FDA profile
- Official device name
- Eyelid Thermal Pulsation System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.5200
- Medical specialty
- Ophthalmic
- FDA definition
- Therapeutic application of heat and massage to the eyelids.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| TearCare MGX System (K252409) | Sight Sciences, Inc. | 2026-04-27 |
| TearCare MGX System (K242786) | Sight Sciences, Inc. | 2025-04-15 |
| Tixel i (TXLI0001) (K240512) | Novoxel , Ltd. | 2024-11-04 |
| TearCare MGX System (K231084) | Sight Sciences, Inc. | 2023-12-27 |
| TearCare System (K213045) | Sight Sciences, Inc. | 2021-12-21 |
| Systane iLux2 (K200400) | Tear Film Innovations, Inc. | 2020-05-21 |
| LipiFlow Thermal Pulsation System (K192623) | Tearscience, Inc. | 2019-10-22 |
| iLux Instrument, iLux Disposable (K172645) | Tear Film Innovations, Inc. | 2017-12-26 |
| LipiFlow Thermal Pulsation System (K161357) | Tearscience, Inc. | 2016-11-04 |
| LIPIFLOW THERMAL PULSATION SYSTEM (K133127) | Tearscience, Inc. | 2013-12-23 |
| LIPIFLOW THERMAL PULSATION SYSTEM (K112704) | Tearscience, Inc. | 2011-12-19 |
| LIPFLOW THERMAL PULSATION SYSTEM (FORMERLY MANUAL MINI SYSTEM) (DEN100017) | Tearscience, Inc. | 2011-06-28 |
Track ORZ automatically
Every clearance here is in the API, with alerts when new ones post.