HKI — Camera, Ophthalmic, Ac-Powered Class II
FDA product code HKI covers "Camera, Ophthalmic, Ac-Powered", a Class II medical device regulated under 21 CFR 886.1120. Submissions are reviewed by the Ophthalmic panel. At least 20 recent 510(k) clearances have been granted under this product code.
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 |
|---|---|---|---|
| K253176 | beyond 700 pty | TearView | June 22, 2026 |
| 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 |