ORZ — Eyelid Thermal Pulsation System Class II
Classification Details
- Product Code
- ORZ
- Device Class
- Class II
- Regulation Number
- 886.5200
- Submission Type
- Review Panel
- OP
- Medical Specialty
- Ophthalmic
- Implant
- No
Definition
Therapeutic application of heat and massage to the eyelids.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K242786 | sight sciences | TearCare MGX System | April 15, 2025 |
| K240512 | novoxel | Tixel i (TXLI0001) | November 4, 2024 |
| K231084 | sight sciences | TearCare MGX System | December 27, 2023 |
| K213045 | sight sciences | TearCare System | December 21, 2021 |
| K200400 | tear film innovations | Systane iLux2 | May 21, 2020 |
| K192623 | tearscience | LipiFlow Thermal Pulsation System | October 22, 2019 |
| K172645 | tear film innovations | iLux Instrument, iLux Disposable | December 26, 2017 |
| K161357 | tearscience | LipiFlow Thermal Pulsation System | November 4, 2016 |
| K133127 | tearscience | LIPIFLOW THERMAL PULSATION SYSTEM | December 23, 2013 |
| K112704 | tearscience | LIPIFLOW THERMAL PULSATION SYSTEM | December 19, 2011 |
| DEN100017 | tearscience | LIPFLOW THERMAL PULSATION SYSTEM (FORMERLY MANUAL MINI SYSTEM) | June 28, 2011 |