Oculogica Inc.
New Richmond, WI, US
OCULOGICA INC. appears in FDA device records in New Richmond, WI. FDA records list 6 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 6 510(k) clearances for Oculogica Inc. between 2018 and 2026. The busiest year on record is 2018, with 1. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2018 | 1 |
| 2019 | 1 |
| 2020 | 1 |
| 2021 | 1 |
| 2025 | 1 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K254086 | EyeBOX SNAP | QEA | Substantially Equivalent | |
| K242116 | EyeBOX EBX-4.1 | QEA | Substantially Equivalent | |
| K212310 | EyeBOX (Model EBX-4) | QEA | Substantially Equivalent | |
| K201841 | EyeBOX | QEA | Substantially Equivalent | |
| K191183 | EyeBOX | QEA | Substantially Equivalent | |
| DEN170091 | EyeBOX | QEA | Unknown |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3014535677 | 3014535677 | OCULOGICA INC. | 1477 South Knowles Avenue, New Richmond, WI 54017 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2398-2019 | EyeBOX Model OCL 02 | A review of the user manual revealed that two precaution statements were missing. | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain