Menlo Park, CA, US · 8 510(k) clearances · 1 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| MRH | — | — | — | 4 | 2026-08-04 |
| ORZ | — | — | — | 4 | 2026-04-27 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2022-03-23 | Class II | Ongoing | Z-1001-2022 | TearCare version 1.0 SmartHubs | — | Ophthalmic devices distributed prior to the recently-obtained 510(k) clearance do not fall within the relevant 510(k) exemption and so their performance charact… |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2026-08-04 | K253760 | OMNI Ultra Surgical System (1-110) | MRH | — | — |
| 2026-04-27 | K252409 | TearCare MGX System | ORZ | — | — |
| 2025-04-15 | K242786 | TearCare MGX System | ORZ | — | — |
| 2023-12-27 | K231084 | TearCare MGX System | ORZ | — | — |
| 2023-08-25 | K232214 | OMNI Surgical System | MRH | — | — |
| 2021-12-21 | K213045 | TearCare System | ORZ | — | — |
| 2021-03-01 | K202678 | OMNI Surgical System | MRH | — | — |
| 2020-08-11 | K201953 | OMNI PLUS Surgical System | MRH | — | — |