ORZ
- Product code
- ORZ
- Device name
- Eyelid Thermal Pulsation System
- Device class
- Class 2
- 21 CFR
- 21 CFR 886.5200
- Medical specialty
- Ophthalmic
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 5
- Summaries archived here
- 4 (direct download)
- 510(k) clearances (all years, FDA)
- 13 (all years; only the last 3 years are listed here)
FDA classification definition
Therapeutic application of heat and massage to the eyelids.
510(k) clearances, last 3 years (5)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K262479 | 2026-08-18 | Sight Sciences, Inc. | TearCare System | |
| K252409 | 2026-04-27 | Sight Sciences, Inc. | TearCare MGX System | |
| K242786 | 2025-04-15 | Sight Sciences, Inc. | TearCare MGX System | |
| K240512 | 2024-11-04 | Novoxel , Ltd. | Tixel i (TXLI0001) | |
| K231084 | 2023-12-27 | Sight Sciences, Inc. | TearCare MGX System | FDA |
Official FDA classification page: ORZ
Classification and pathway per current FDA publications. Data from openFDA (CC0).