EYE-SYNC
FDA 510(k) clearance K202927 · decided 2021-10-02
Clearance details
- K-number
- K202927
- Device name
- EYE-SYNC
- Applicant
- Syncthink, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2020-09-29
- Decision date
- 2021-10-02
- Days to decision
- 368 days
- Clearance type
- Traditional
- Product code
- QEA
- Device class
- 2
- Regulation number
- 882.1455
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Palo Alto, CA, 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 EBX-4.1 (K242116) | Oculogica, Inc. | 2025-04-04 |
| EyeBOX (Model EBX-4) (K212310) | Oculogica, Inc. | 2021-12-22 |
| 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
| Record | Firm | Date |
|---|---|---|
| NeuroSync EYE-SYNC containing Pico Neo 2 Headsets. Each unit consists of a Pico Neo 2 head recall (Z-2114-2025) | NeuroSync, Inc. | 2025-07-11 |