Diagnostics 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 3 spellings of its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list Oculogica, Inc. with 5 510(k) clearances, 3 AI-enabled devices and 1 device recall. The most recent is a 510(k) clearance dated Jun 5, 2026: EyeBOX SNAP.
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.
| Jun 5, 2026 | EyeBOX SNAPK254086 · QEA | 510(k) clearances |
| Apr 4, 2025 | EyeBOX EBX-4.1K242116 · QEA | 510(k) clearances |
| Dec 22, 2021 | EyeBOX (Model EBX-4)K212310 · QEA | 510(k) clearances |
| Sep 6, 2020 | EyeBOXK201841 · QEA | 510(k) clearances |
| Sep 6, 2020 | EyeBOXK201841 · Neurology | AI-enabled devices |
| Jul 31, 2019 | EyeBOXK191183 · QEA | 510(k) clearances |
| Jul 31, 2019 | EyeBOXK191183 · Neurology | AI-enabled devices |
| Apr 16, 2019 | EyeBOX Model OCL 02Class II · A review of the user manual revealed that two precaution statements were missing. | Device recalls |
| Dec 28, 2018 | EyeBOXDEN170091 · QEA | 510(k) clearances |
| Dec 28, 2018 | EyeBOXDEN170091 · Neurology | AI-enabled devices |
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
