Sight Sciences, Inc.
Medical device manufacturer in Menlo Park, CA.
13510(k) clearances
0PMA approvals
1recalls
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K262479 | TearCare SystemORZ · Special | 08/18/2026SE |
| K253760 | OMNI Ultra Surgical System (1-110)MRH · Traditional | 08/04/2026SE |
| K252409 | TearCare MGX SystemORZ · Traditional | 04/27/2026SE |
| K242786 | TearCare MGX SystemORZ · Traditional | 04/15/2025SE |
| K231084 | TearCare MGX SystemORZ · Traditional | 12/27/2023SE |
| K232214 | OMNI Surgical SystemMRH · Special | 08/25/2023SE |
| K213045 | TearCare SystemORZ · Traditional | 12/21/2021SE |
| K202678 | OMNI Surgical SystemMRH · Traditional | 03/01/2021SE |
| K201953 | OMNI PLUS Surgical SystemMRH · Special | 08/11/2020SE |
| K173332 | OMNI Surgical SystemMRH · Traditional | 12/21/2017SE |
| K171905 | VISCO 360 Viscosurgical SystemMRH · Special | 07/27/2017SE |
| K143205 | Viscoelastic InjectorMRH · Special | 12/05/2014SE |
| K132494 | Viscoelastic InjectorMRH · Traditional | 10/22/2013SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-1001-2022 Class II | TearCare version 1.0 SmartHubsOphthalmic devices distributed prior to the recently-obtained 510(k) clearance do not fall within the… | 03/23/2022Open, Classified |