HKI — Camera, Ophthalmic, Ac-Powered Class II
FDA Device Classification
Classification Details
- Product Code
- HKI
- Device Class
- Class II
- Regulation Number
- 886.1120
- Submission Type
- Review Panel
- OP
- Medical Specialty
- Ophthalmic
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K251353 | phelcom technologies | Eyer 2 | January 16, 2026 |
| K252120 | remidio innovative solutions private limited | Fundus On Phone Non Mydriatic (FOP NM-10) | December 12, 2025 |
| K250770 | optina diagnostics | Optina-4C (MHRC-C1N) | September 4, 2025 |
| K243600 | forus health pvt | 3nethra neo HD FA; 3nethra neo HD | August 14, 2025 |
| K250683 | optain health | Resolve Fundus Camera | April 30, 2025 |
| K243664 | ai optics | Sentinel Camera | December 17, 2024 |
| K242508 | verily life sciences | Verily Numetric Retinal Camera | December 9, 2024 |
| K241049 | canon | CANON Fundus Camera CR-10 (CR-10) | May 15, 2024 |
| K231230 | optina diagnostics | Optina-4C (MHRC-C1N) | December 5, 2023 |
| K230627 | zilia | Zilia Ocular FC (ZIL-10002) | November 20, 2023 |
| K223575 | neolight | Phoenix ICON, Phoenix ICON GO | September 6, 2023 |
| K223381 | welch allyn | iExaminer System with Panoptic Plus | March 15, 2023 |
| K221329 | phelcom technologies | Eyer Retinal Camera NM-STD | February 22, 2023 |
| K221111 | topcon corporation | Non-Mydriatic Retinal Camera NW500 | August 29, 2022 |
| K210197 | crystalvue medical corporation | NFC-600 Automated Portable Retinal Camera | April 13, 2021 |
| K203500 | natus medical incorporated dba excel-tech ltd. (xltek) | RetCam Envision | April 13, 2021 |
| K202097 | huvitz co | Fundus Camera | February 2, 2021 |
| K202221 | luneau technology operations | VX650 | January 29, 2021 |
| K201325 | optomed | Optomed Smartscope M5 with Optomed Smartscope FA | November 20, 2020 |
| K201122 | canon | Canon non-mydriatic retinal camera CR series | July 23, 2020 |