EyeBOX EBX-4.1
FDA 510(k) clearance K242116 · decided 2025-04-04
Clearance details
- K-number
- K242116
- Device name
- EyeBOX EBX-4.1
- Applicant
- Oculogica, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2024-07-19
- Decision date
- 2025-04-04
- Days to decision
- 259 days
- Clearance type
- Traditional
- Product code
- QEA
- Device class
- 2
- Regulation number
- 882.1455
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- New Richmond, WI, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| EyeBOX SNAP (K254086) | Oculogica, Inc. | 2026-06-05 |
| EyeBOX (Model EBX-4) (K212310) | Oculogica, Inc. | 2021-12-22 |
| EYE-SYNC (K202927) | Syncthink, Inc. | 2021-10-02 |
| EyeBOX (K201841) | Oculogica, Inc. | 2020-09-06 |
| EyeBOX (K191183) | Oculogica, Inc. | 2019-07-31 |
| EyeBOX (DEN170091) | Oculogica, Inc. | 2018-12-28 |
Recalls involving this device
No recalls on record reference this clearance.