Eyer 2
FDA 510(k) clearance K251353 · decided 2026-01-16
Clearance details
- K-number
- K251353
- Device name
- Eyer 2
- Applicant
- Phelcom Technologies
- Decision
- Substantially Equivalent
- Date received
- 2025-04-30
- Decision date
- 2026-01-16
- Days to decision
- 261 days
- Clearance type
- Traditional
- Product code
- HKI
- Device class
- 2
- Regulation number
- 886.1120
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- São Carlos, BR
- 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 |
|---|---|---|
| TearView (K253176) | Beyond 700 Pty, Ltd. | 2026-06-22 |
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| Optina-4C (MHRC-C1N) (K250770) | Optina Diagnostics, Inc. | 2025-09-04 |
| 3nethra neo HD FA; 3nethra neo HD (K243600) | Forus Health Pvt.Ltd | 2025-08-14 |
| Resolve Fundus Camera (K250683) | Optain Health, Inc. | 2025-04-30 |
| Sentinel Camera (K243664) | Ai Optics | 2024-12-17 |
| Verily Numetric Retinal Camera (K242508) | Verily Life Sciences, LLC | 2024-12-09 |
| CANON Fundus Camera CR-10 (CR-10) (K241049) | Canon, Inc. | 2024-05-15 |
| Optina-4C (MHRC-C1N) (K231230) | Optina Diagnostics, Inc. | 2023-12-05 |
| Zilia Ocular FC (ZIL-10002) (K230627) | Zilia, Inc. | 2023-11-20 |
| Phoenix ICON, Phoenix ICON GO (K223575) | Neolight, LLC | 2023-09-06 |
| iExaminer System with Panoptic Plus (K223381) | Welch Allyn, Inc. | 2023-03-15 |
Recalls involving this device
No recalls on record reference this clearance.