Data / Medical devices / United States / Sight Sciences, Inc.
Sight Sciences, Inc.: FDA-registered device maker in Menlo Park, CA, United States, 7 510(k) clearances
Sight Sciences, Inc. is registered with the FDA (registration 3010363671) in Menlo Park, CA, United States. It lists 5 device types. The FDA files 7 510(k) clearances under its listings, the newest dated August 18, 2026. 1 recall event names it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3010363671
- Address
- 4040 Campbell Ave. Suite 100, Menlo Park, CA, United States, 94025
- Owner or operator
- Sight Sciences, Inc. (10044440)
- Roles
- Complaint file establishment, Repackager or relabeler, Specification developer
- First device listed
- June 12, 2013
- Registered through
- 2027
- Brand names listed
- Clearance Assistant, Clearance Assistant Plus, OMNI Edge Surgical System, OMNI Surgical System, OMNI Ultra Surgical System, SION Surgical Instrument, TearCare MGX System, TearCare System and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Curette, Ophthalmic | HNZ | 1 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Expressor | HNS | 1 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Eyelid Thermal Pulsation System | ORZ | 2 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Pump, Infusion, Ophthalmic | MRH | 2 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Trabeculotome | HMZ | 1 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 18, 2026 | K262479 | TearCare System | ORZ | Substantially Equivalent | Sight Sciences, Inc. | accessdata.fda.gov |
| August 4, 2026 | K253760 | OMNI Ultra Surgical System (1-110) | MRH | Substantially Equivalent | Sight Sciences, Inc. | accessdata.fda.gov |
| April 15, 2025 | K242786 | TearCare MGX System | ORZ | Substantially Equivalent | Sight Sciences, Inc. | accessdata.fda.gov |
| December 27, 2023 | K231084 | TearCare MGX System | ORZ | Substantially Equivalent | Sight Sciences, Inc. | accessdata.fda.gov |
| August 25, 2023 | K232214 | OMNI Surgical System | MRH | Substantially Equivalent | Sight Sciences, Inc. | accessdata.fda.gov |
| December 21, 2021 | K213045 | TearCare System | ORZ | Substantially Equivalent | Sight Sciences, Inc. | accessdata.fda.gov |
| March 1, 2021 | K202678 | OMNI Surgical System | MRH | Substantially Equivalent | Sight Sciences, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| March 23, 2022 | 89939 | Class II | Ongoing | 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 characteristics were not evaluated by the FDA prior to distribution. | accessdata.fda.gov |
Compare with other makers
- All makers of Eyelid Thermal Pulsation System
- All makers of Pump, Infusion, Ophthalmic
- All makers of Trabeculotome
- All makers of Curette, Ophthalmic
- All makers of Expressor
Updated August 18, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.