Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list Sight Sciences with 13 510(k) clearances and 1 device recall. The most recent is a 510(k) clearance dated Aug 18, 2026: TearCare System.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Date | Record | Source |
|---|---|---|
| Aug 18, 2026 | TearCare SystemK262479 · ORZ | 510(k) clearances |
| Aug 4, 2026 | OMNI Ultra Surgical System (1-110)K253760 · MRH | 510(k) clearances |
| Apr 27, 2026 | TearCare MGX SystemK252409 · ORZ | 510(k) clearances |
| Apr 15, 2025 | TearCare MGX SystemK242786 · ORZ | 510(k) clearances |
| Dec 27, 2023 | TearCare MGX SystemK231084 · ORZ | 510(k) clearances |
| Aug 25, 2023 | OMNI Surgical SystemK232214 · MRH | 510(k) clearances |
| Mar 23, 2022 | TearCare version 1.0 SmartHubsClass II · Ophthalmic devices distributed prior to the recently-obtained 510(k) clearance do not fall within the relevant 510(k) ex | Device recalls |
| Dec 21, 2021 | TearCare SystemK213045 · ORZ | 510(k) clearances |
| Mar 1, 2021 | OMNI Surgical SystemK202678 · MRH | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
