Product code HKI
- Device name
- Camera, Ophthalmic, Ac-Powered
- Medical specialty
- Ophthalmic
- Device class
- 2
- Regulation number
- 886.1120
- Review panel
- OP
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K251353 | Eyer 2 | Phelcom Technologies | 2026-01-16 |
| K252120 | Fundus On Phone Non Mydriatic (FOP NM-10) | Remidio Innovative Solutions Private Limited | 2025-12-12 |
| K250770 | Optina-4C (MHRC-C1N) | Optina Diagnostics, Inc. | 2025-09-04 |
| K243600 | 3nethra neo HD FA; 3nethra neo HD | Forus Health Pvt.Ltd | 2025-08-14 |
| K250683 | Resolve Fundus Camera | Optain Health, Inc. | 2025-04-30 |
| K243664 | Sentinel Camera | Ai Optics | 2024-12-17 |
| K242508 | Verily Numetric Retinal Camera | Verily Life Sciences, LLC | 2024-12-09 |
| K241049 | CANON Fundus Camera CR-10 (CR-10) | Canon, Inc. | 2024-05-15 |
| K231230 | Optina-4C (MHRC-C1N) | Optina Diagnostics, Inc. | 2023-12-05 |
| K230627 | Zilia Ocular FC (ZIL-10002) | Zilia, Inc. | 2023-11-20 |
| K223575 | Phoenix ICON, Phoenix ICON GO | Neolight, LLC | 2023-09-06 |
| K223381 | iExaminer System with Panoptic Plus | Welch Allyn, Inc. | 2023-03-15 |
| K221329 | Eyer Retinal Camera NM-STD | Phelcom Technologies | 2023-02-22 |
| K221111 | Non-Mydriatic Retinal Camera NW500 | Topcon Corporation | 2022-08-29 |
| K203500 | RetCam Envision | Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) | 2021-04-13 |
| K210197 | NFC-600 Automated Portable Retinal Camera | Crystalvue Medical Corporation | 2021-04-13 |
| K202097 | Fundus Camera | Huvitz Co., Ltd. | 2021-02-02 |
| K202221 | VX650 | Luneau Technology Operations | 2021-01-29 |
| K201325 | Optomed Smartscope M5 with Optomed Smartscope FA | Optomed Oyj | 2020-11-20 |
| K201122 | Canon non-mydriatic retinal camera CR series | Canon, Inc. | 2020-07-23 |
| K193319 | XyCAM RI, XyCAM RI System, XyCAM Retinal Imaging System | Vasoptic Medical, Inc. | 2020-06-01 |
| K200254 | Mydriatic Hyperspectral Retinal Camera (MHRC-C1) | Optina Diagnostics | 2020-04-27 |
| K190954 | Fundus Camera | Chongqing Bio Newvision Medical Equipment , Ltd. | 2020-01-22 |
| K191945 | KOWA nonmyd 8 | Kowa Company , Ltd. | 2019-09-10 |
| K190573 | KOWA DR-1a | Kowa Company , Ltd. | 2019-06-04 |
| K190198 | Microperimeter MP-3, Microperimeter MP-3 Type S | Nidek Co., Ltd. | 2019-04-01 |
| K182199 | NFC-700 non-mydriatic auto fundus camera | Crystalvue Medical Corporation | 2019-01-02 |
| K183059 | 3nethra neo | Forus Health Pvt.Ltd | 2018-12-21 |
| K182506 | LipiScan Dynamic Meibomian Imager | Tearscience, Inc. | 2018-12-10 |
| K182263 | RetCam 3 ; RetCam Shuttle ; RetCam Portable | Natus Medical Incorporated | 2018-09-07 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10857253006085 | Phoenix ICON GO Control Box | Phoenix Clinical | 2026-05-14 |
| 00857253006149 | Phoenix ICON GO & FA Module with Training Kit | Phoenix Clinical | 2026-04-03 |
| 00857253006132 | Phoenix ICON GO with Training Kit | Phoenix Clinical | 2026-04-03 |
| 00857253006118 | Phoenix ICON & FA Module with Training Kit | Phoenix Clinical | 2026-04-03 |
| 00857253006101 | Phoenix ICON with Training Kit | Phoenix Clinical | 2026-04-03 |
| 00857253006071 | Diffuser | Phoenix Clinical | 2026-04-03 |
| 00857253006033 | FA Module | Phoenix Clinical | 2026-04-03 |
| 00857253006019 | ICON Handpiece | Phoenix Clinical | 2026-04-03 |
| 08034028770517 | ESSILOR | VISIA IMAGING SRL | 2024-11-04 |
| 08034028770487 | MYAH | VISIA IMAGING SRL | 2023-10-12 |
| 00850003069302 | IMAGEnet 6 | TOPCON HEALTHCARE SOLUTIONS, INC. | 2020-12-09 |
| 00850003069241 | IMAGEnet 6 | TOPCON HEALTHCARE SOLUTIONS, INC. | 2020-06-23 |
| B667PROTOZ1 | PROTOZ | NEXT SIGHT SRL | 2019-12-09 |
| 00850003069203 | IMAGEnet 6 | TOPCON HEALTHCARE SOLUTIONS, INC. | 2019-09-19 |
| 00850003069166 | IMAGEnet 6 | TOPCON HEALTHCARE SOLUTIONS, INC. | 2019-09-19 |
| 00850003069142 | IMAGEnet 6 | TOPCON HEALTHCARE SOLUTIONS, INC. | 2019-08-05 |
| 00850003069074 | IMAGEnet 6 | TOPCON HEALTHCARE SOLUTIONS, INC. | 2019-04-24 |
| 00850003069050 | IMAGEnet 6 | TOPCON HEALTHCARE SOLUTIONS, INC. | 2019-02-14 |
| 00850003069029 | IMAGEnet 6 | TOPCON HEALTHCARE SOLUTIONS, INC. | 2019-02-13 |
| 00850003069005 | IMAGEnet 6 | TOPCON HEALTHCARE SOLUTIONS, INC. | 2019-02-12 |
| 08053677040093 | EIDON | CENTERVUE SPA | 2018-07-23 |
| B667NEXY1 | NEXY | NEXT SIGHT SRL | 2018-06-18 |
| 00842000100140 | Merge Eye Station | MERGE HEALTHCARE SOLUTIONS INC. | 2016-12-01 |
| 08056098470319 | S4 OPTIK | COSTRUZIONI STRUMENTI OFTALMICI C.S.O. SRL | 2016-09-13 |
| 00858848006179 | iFusion | OPTOVUE, INC. | 2016-08-31 |
| 00858848006186 | iFusion | OPTOVUE, INC. | 2016-08-31 |
| 00858848006193 | iFusion | OPTOVUE, INC. | 2016-08-31 |
| 00858848006209 | iFusion | OPTOVUE, INC. | 2016-08-31 |
| 00858848006230 | iFusion | OPTOVUE, INC. | 2016-08-31 |
| 08053677040017 | DRS | CENTERVUE SPA | 2016-07-29 |