ORZ — Eyelid Thermal Pulsation System Class II
FDA product code ORZ covers "Eyelid Thermal Pulsation System", a Class II medical device regulated under 21 CFR 886.5200. Submissions are reviewed by the Ophthalmic panel. At least 12 recent 510(k) clearances have been granted under this product code.
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 |
|---|---|---|---|
| K252409 | sight sciences | TearCare MGX System | April 27, 2026 |
| 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 |