FDA Product Code
FDA Product Code ORZ — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Ophthalmic
- 21 CFR Citation
- 886.5200
510(k) Clearances — 13 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K262479 | TearCare System | Sight Sciences, Inc. | 2026-08-18 | Special | PDF ↗ |
| K252409 | TearCare MGX System | Sight Sciences, Inc. | 2026-04-27 | Traditional | PDF ↗ |
| K242786 | TearCare MGX System | Sight Sciences, Inc. | 2025-04-15 | Traditional | PDF ↗ |
| K240512 | Tixel i (TXLI0001) | Novoxel , Ltd. | 2024-11-04 | Traditional | PDF ↗ |
| K231084 | TearCare MGX System | Sight Sciences, Inc. | 2023-12-27 | Traditional | PDF ↗ |
| K213045 | TearCare System | Sight Sciences, Inc. | 2021-12-21 | Traditional | PDF ↗ |
| K200400 | Systane iLux2 | Tear Film Innovations, Inc. | 2020-05-21 | Traditional | PDF ↗ |
| K192623 | LipiFlow Thermal Pulsation System | Tearscience, Inc. | 2019-10-22 | Special | PDF ↗ |
| K172645 | iLux Instrument, iLux Disposable | Tear Film Innovations, Inc. | 2017-12-26 | Traditional | PDF ↗ |
| K161357 | LipiFlow Thermal Pulsation System | Tearscience, Inc. | 2016-11-04 | Special | PDF ↗ |
| K133127 | LIPIFLOW THERMAL PULSATION SYSTEM | Tearscience, Inc. | 2013-12-23 | Traditional | PDF ↗ |
| K112704 | LIPIFLOW THERMAL PULSATION SYSTEM | Tearscience, Inc. | 2011-12-19 | Traditional | PDF ↗ |
| DEN100017 | LIPFLOW THERMAL PULSATION SYSTEM (FORMERLY MANUAL MINI SYSTEM) | Tearscience, Inc. | 2011-06-28 | Post-NSE | — |
Product code ORZ · Class II · Ophthalmic. Data: openFDA.