Smartscope Pro Retinal Set
The Optomed Smartscope retinal set combines an M5 digital camera with the EY4 ophthalmic optics module to capture images and video of the eye’s fundus. It is a prescription imaging device…
The Optomed Smartscope retinal set combines an M5 digital camera with the EY4 ophthalmic optics module to capture images and video of the eye’s fundus. It is a prescription imaging device that can be used without pupil-dilating medication, although imaging with dilation is also supported.
The EY4 module uses visible white and infrared LED illumination, with red target lights to help fix the eye’s position. The camera’s CMOS sensor records the image, and an attached colour LCD provides the viewing display.
Listed Item
Optomed Smartscope Pro retinal set M5WEY4
Image Transfer
Images are stored on a flash memory card and transferred to a computer through USB. The set includes an eye cup, charging and image-transfer cradle, and slit-lamp adapter. The camera uses a rechargeable battery.
Who Else Makes It
Concentrated in Jiangsu (1), Shanghai (1), Chongqing (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Mediworks Precision Instruments Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 13 |
| Taizhou City K&W International Trade Co., Ltd. | Jiangyan | Jiangsu | Repacker / relabeller | 38 |
| Chongqing BIO Newvision Medical Equipment Ltd. | Chongqing | Chongqing | Manufacturer | 2 |
Record
| Listed by | Optomed, Finland |
|---|---|
| FDA product code | HKI |
| Device type | Camera, Ophthalmic, Ac-Powered |
| Device class | Class 2 |
| Regulation | 21 CFR 886.1120 |
| Establishment | Specification developer, Manufacturer, Exporter |
| 510(k) | K132186 |
| Record published | 2025-11-13 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 60100065A | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Jedmed | Jedmed Instrument Company | 15 |
| Neolight | Neolight, LLC | 11 |
| Natus | Xltek | 6 |
| RetCam Envision | Natus Medical Denmark ApS | 6 |
| 3nethra | Forus Health Pvt.ltd., | 6 |
| iCam | Optovue, Inc. | 5 |
| iFusion | Optovue, Inc. | 5 |
| Canon Inc. | Canon Inc. | 4 |
| Camera, Ophthalmic, Ac-Powered | Chongqing Kanghuaruiming S&T Co., Ltd.. | 4 |
| 3D Optical Coherence Tomography 3D OCT-1(Type:Maestro2) | Topcon Corp. | 3 |
| Retinal Camera TRC-50DX | Topcon Corp. | 3 |
| NON-Mydriatic Retinal Camera TRC-NW400 | Topcon Corp. | 2 |
Showing 12 of 123. All products under Camera, Ophthalmic, Ac-Powered
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K180378 | 2018-04-05 |
| K163021 | 2017-04-11 |
| K132186 | 2013-12-18 |
| K110986 | 2011-05-16 |
| K092056 | 2009-10-01 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.