HKI
- Product code
- HKI
- Device name
- Camera, Ophthalmic, Ac-Powered
- Device class
- Class 2
- 21 CFR
- 21 CFR 886.1120
- Medical specialty
- Ophthalmic
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 11
- Summaries archived here
- 11 (direct download)
- 510(k) clearances (all years, FDA)
- 157 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (11)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K253176 | 2026-06-22 | Beyond 700 Pty, Ltd. | TearView | |
| K251353 | 2026-01-16 | Phelcom Technologies | Eyer 2 | |
| K252120 | 2025-12-12 | Remidio Innovative Solutions Private L… | Fundus On Phone Non Mydriatic (FOP NM-10) | |
| K250770 | 2025-09-04 | Optina Diagnostics, Inc. | Optina-4C (MHRC-C1N) | |
| K243600 | 2025-08-14 | Forus Health Pvt.Ltd | 3nethra neo HD FA; 3nethra neo HD | |
| K250683 | 2025-04-30 | Optain Health, Inc. | Resolve Fundus Camera | |
| K243664 | 2024-12-17 | Ai Optics | Sentinel Camera | |
| K242508 | 2024-12-09 | Verily Life Sciences, LLC | Verily Numetric Retinal Camera | |
| K241049 | 2024-05-15 | Canon, Inc. | CANON Fundus Camera CR-10 (CR-10) | |
| K231230 | 2023-12-05 | Optina Diagnostics, Inc. | Optina-4C (MHRC-C1N) | |
| K230627 | 2023-11-20 | Zilia, Inc. | Zilia Ocular FC (ZIL-10002) |
Official FDA classification page: HKI
Classification and pathway per current FDA publications. Data from openFDA (CC0).