Sight Sciences, Inc.: FDA clearances and approvals
Sight Sciences, Inc. has 13 FDA 510(k) clearances (first 2013, latest 2026), across 2 product codes in 1 review panel. Median 510(k) review time: 74 days. Since 2017 its median was 90 days, against 116 days for all cleared 510(k)s in the same product codes. openFDA lists 1 product recall by a recalling firm named Sight Sciences, Inc. It is the industry lead sponsor of 11 device clinical trials on ClinicalTrials.gov. It files with the SEC as Sight Sciences, Inc. (SGHT).
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2013 | 1 | 74 |
| 2014 | 1 | 28 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 2 | 45 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 1 | 28 |
| 2021 | 2 | 128 |
| 2022 | 0 | — |
| 2023 | 2 | 142 |
| 2024 | 0 | — |
| 2025 | 1 | 211 |
| 2026 | 3 | 252 |
Review time against the same product codes
Since 2017, Sight Sciences, Inc.'s cleared 510(k)s took a median 90 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 116 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MRH | Pump, Infusion, Ophthalmic | 8 | 8 |
| ORZ | Eyelid Thermal Pulsation System | 5 | 5 |
Review panels
- Ophthalmic (13)
Most recent Sight Sciences, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K262479 | TearCare System | ORZ | 2026-08-18 | 29 |
| K253760 | OMNI Ultra Surgical System (1-110) | MRH | 2026-08-04 | 252 |
| K252409 | TearCare MGX System | ORZ | 2026-04-27 | 269 |
| K242786 | TearCare MGX System | ORZ | 2025-04-15 | 211 |
| K231084 | TearCare MGX System | ORZ | 2023-12-27 | 254 |
| K232214 | OMNI Surgical System | MRH | 2023-08-25 | 30 |
| K213045 | TearCare System | ORZ | 2021-12-21 | 90 |
| K202678 | OMNI Surgical System | MRH | 2021-03-01 | 167 |
| K201953 | OMNI PLUS Surgical System | MRH | 2020-08-11 | 28 |
| K173332 | OMNI Surgical System | MRH | 2017-12-21 | 59 |
3 earlier clearances. See the full list in Caduvo.
Recalls
1 product recalls in 1 recall events; 1 initiated in the last five years. Most recent: 2022-03-23.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Device clinical trials
Sight Sciences, Inc. is the industry lead sponsor of 11 device studies on ClinicalTrials.gov (3 active or recruiting). Most recent:
- NCT07365735: TearCare MGX™ System With and Without Warming Hold (Active not recruiting, started 2026-03-17)
- NCT06991270: OMNI 3.1 Surgical System in Subjects With Primary Open-Angle Glaucoma (Recruiting, started 2026-02)
- NCT06948773: A Study of the Helix Surgical System in Primary Open-Angle Glaucoma (POAG) and Cataract (HELIX) (Recruiting, started 2025-05-21)
- NCT05044793: A Clinical Study To Assess The Safety And Effectiveness Of The OMNI® Surgical System (Completed, started 2021-09-01)
- NCT04872348: An Observational Multicenter Clinical Study To Assess The Safety And Effectiveness Of The OMNI® Surgical System In Pseudophakic Eyes With Primary Open Angle Glaucoma (ORION 2.0) (Completed, started 2021-07-01)
SEC filings
Sight Sciences, Inc. (SGHT): EDGAR filings, CIK 1531177. Matched by exact company name.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of Sight Sciences, Inc.'s product codes (a text match, not an official crosswalk):
- A4220 — Refill kit for implantable infusion pump (via MRH)
- E0786 — Implantable programmable infusion pump, replacement (excludes implantable intraspinal catheter) (via MRH)
Frequently asked questions
How many FDA 510(k) clearances does Sight Sciences, Inc. have?
Sight Sciences, Inc. has 13 FDA 510(k) clearances (first 2013, latest 2026), across 2 product codes in 1 review panel.
How long does FDA take to clear Sight Sciences, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Sight Sciences, Inc.'s cleared 510(k)s is 74 days. Since 2017: 90 days, versus 116 days for all cleared 510(k)s in the same product codes.
What devices does Sight Sciences, Inc. make?
Its most frequent FDA product codes are MRH (Pump, Infusion, Ophthalmic, 8); ORZ (Eyelid Thermal Pulsation System, 5).
Has Sight Sciences, Inc. had device recalls?
openFDA lists 1 product recall in 1 recall event by a recalling firm whose name matches Sight Sciences, Inc; the most recent began 2022-03-23. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 13 Sight Sciences, Inc. clearances with predicates and recalls
- Run predicate analysis for product code MRH, Sight Sciences, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.