HKI · Camera, Ophthalmic, Ac-Powered
Ophthalmic · 21 CFR 886.1120 · Class 2
Overview
| Product Code | HKI |
|---|---|
| Device Name | Camera, Ophthalmic, Ac-Powered |
| Regulation | 21 CFR 886.1120 |
| Device Class | Class 2 |
| Review Panel | Ophthalmic |
| 3rd-Party Reviewable | Yes |
Identification
An ophthalmic camera is an AC-powered device intended to take photographs of the eye and the surrounding area.
Classification Rationale
Class II (special controls). The device, when it is a photorefractor or a general-use ophthalmic camera, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.
Special Controls
*Classification.* Class II (special controls). The device, when it is a photorefractor or a general-use ophthalmic camera, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.
Recent Cleared Devices (20 of 156)
Showing 20 most recent of 156 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K251353 | Eyer 2 | Phelcom Technologies | Jan 16, 2026 | SESE |
| K252120 | Fundus On Phone Non Mydriatic (FOP NM-10) | Remidio Innovative Solutions Private Limited | Dec 12, 2025 | SESE |
| K250770 | Optina-4C (MHRC-C1N) | Optina Diagnostics, Inc. | Sep 4, 2025 | SESE |
| K243600 | 3nethra neo HD FA; 3nethra neo HD | Forus Health Pvt.Ltd | Aug 14, 2025 | SESE |
| K250683 | Resolve Fundus Camera | Optain Health, Inc. | Apr 30, 2025 | SESE |
| K243664 | Sentinel Camera | Ai Optics | Dec 17, 2024 | SESE |
| K242508 | Verily Numetric Retinal Camera | Verily Life Sciences, LLC | Dec 9, 2024 | SESE |
| K241049 | CANON Fundus Camera CR-10 (CR-10) | Canon, Inc. | May 15, 2024 | SESE |
| K231230 | Optina-4C (MHRC-C1N) | Optina Diagnostics, Inc. | Dec 5, 2023 | SESE |
| K230627 | Zilia Ocular FC (ZIL-10002) | Zilia, Inc. | Nov 20, 2023 | SESE |
| K223575 | Phoenix ICON, Phoenix ICON GO | Neolight, LLC | Sep 6, 2023 | SESE |
| K223381 | iExaminer System with Panoptic Plus | Welch Allyn, Inc. | Mar 15, 2023 | SESE |
| K221329 | Eyer Retinal Camera NM-STD | Phelcom Technologies | Feb 22, 2023 | SESE |
| K221111 | Non-Mydriatic Retinal Camera NW500 | Topcon Corporation | Aug 29, 2022 | SESE |
| K210197 | NFC-600 Automated Portable Retinal Camera | Crystalvue Medical Corporation | Apr 13, 2021 | SESE |
| K203500 | RetCam Envision | Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) | Apr 13, 2021 | SESE |
| K202097 | Fundus Camera | Huvitz Co., Ltd. | Feb 2, 2021 | SESE |
| K202221 | VX650 | Luneau Technology Operations | Jan 29, 2021 | SESE |
| K201325 | Optomed Smartscope M5 with Optomed Smartscope FA | Optomed Oyj | Nov 20, 2020 | SESE |
| K201122 | Canon non-mydriatic retinal camera CR series | Canon, Inc. | Jul 23, 2020 | SESE |
Top Applicants
- Canon USA, Inc. — 12 clearances
- Kowa Co. , Ltd. — 12 clearances
- Canon, Inc. — 7 clearances
- Optomed OY — 5 clearances
- Topcon Corp. — 5 clearances
