Browse hierarchy: [Ophthalmic (OP)](/submissions/OP) → [Subpart B — Diagnostic Devices](/submissions/OP/subpart-b%E2%80%94diagnostic-devices) → [21 CFR 886.1120](/submissions/OP/subpart-b%E2%80%94diagnostic-devices/886.1120) → HKI — Camera, Ophthalmic, Ac-Powered # HKI · Camera, Ophthalmic, Ac-Powered _Ophthalmic · 21 CFR 886.1120 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HKI ## Overview - **Product Code:** HKI - **Device Name:** Camera, Ophthalmic, Ac-Powered - **Regulation:** [21 CFR 886.1120](/submissions/OP/subpart-b%E2%80%94diagnostic-devices/886.1120) - **Device Class:** 2 - **Review Panel:** [Ophthalmic](/submissions/OP) - **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](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HKI/K251353.md) | Eyer 2 | Phelcom Technologies | Jan 16, 2026 | SESE | | [K252120](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HKI/K252120.md) | Fundus On Phone Non Mydriatic (FOP NM-10) | Remidio Innovative Solutions Private Limited | Dec 12, 2025 | SESE | | [K250770](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HKI/K250770.md) | Optina-4C (MHRC-C1N) | Optina Diagnostics, Inc. | Sep 4, 2025 | SESE | | [K243600](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HKI/K243600.md) | 3nethra neo HD FA; 3nethra neo HD | Forus Health Pvt.Ltd | Aug 14, 2025 | SESE | | [K250683](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HKI/K250683.md) | Resolve Fundus Camera | Optain Health, Inc. | Apr 30, 2025 | SESE | | [K243664](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HKI/K243664.md) | Sentinel Camera | Ai Optics | Dec 17, 2024 | SESE | | [K242508](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HKI/K242508.md) | Verily Numetric Retinal Camera | Verily Life Sciences, LLC | Dec 9, 2024 | SESE | | [K241049](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HKI/K241049.md) | CANON Fundus Camera CR-10 (CR-10) | Canon, Inc. | May 15, 2024 | SESE | | [K231230](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HKI/K231230.md) | Optina-4C (MHRC-C1N) | Optina Diagnostics, Inc. | Dec 5, 2023 | SESE | | [K230627](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HKI/K230627.md) | Zilia Ocular FC (ZIL-10002) | Zilia, Inc. | Nov 20, 2023 | SESE | | [K223575](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HKI/K223575.md) | Phoenix ICON, Phoenix ICON GO | Neolight, LLC | Sep 6, 2023 | SESE | | [K223381](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HKI/K223381.md) | iExaminer System with Panoptic Plus | Welch Allyn, Inc. | Mar 15, 2023 | SESE | | [K221329](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HKI/K221329.md) | Eyer Retinal Camera NM-STD | Phelcom Technologies | Feb 22, 2023 | SESE | | [K221111](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HKI/K221111.md) | Non-Mydriatic Retinal Camera NW500 | Topcon Corporation | Aug 29, 2022 | SESE | | [K210197](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HKI/K210197.md) | NFC-600 Automated Portable Retinal Camera | Crystalvue Medical Corporation | Apr 13, 2021 | SESE | | [K203500](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HKI/K203500.md) | RetCam Envision | Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) | Apr 13, 2021 | SESE | | [K202097](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HKI/K202097.md) | Fundus Camera | Huvitz Co., Ltd. | Feb 2, 2021 | SESE | | [K202221](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HKI/K202221.md) | VX650 | Luneau Technology Operations | Jan 29, 2021 | SESE | | [K201325](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HKI/K201325.md) | Optomed Smartscope M5 with Optomed Smartscope FA | Optomed Oyj | Nov 20, 2020 | SESE | | [K201122](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HKI/K201122.md) | 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 --- **Source:** [https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HKI](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HKI) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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