| K-number | K251353 |
| Device name | Eyer 2 |
| Applicant | Phelcom Technologies |
| Product code | HKI |
| Device class | Class II |
| Decision date | Jan 16, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 886.1120 |
The Eyer 2 is a portable fundus camera that attaches to Samsung Galaxy S21, S22, or S23 smartphones to capture fundus images and videos. It includes an optional front module for imaging the ocular surface and surrounding areas, including meibomian glands. Images and videos are stored in the smartphone's internal database and can be transferred via DICOM, DICOMWEB, FTPS, or local folder connections. It is designed for use by healthcare professionals in medical environments without mydriasis, though mydriatic drops may be used if needed.
The Eyer 2 combines imaging functions across multiple predicate devices: color fundus photography, green-channel fundus photography, infrared fundus imaging, white and blue-light ocular surface imaging, and meibomian gland imaging under near-infrared illumination. It features diopter compensation from -20D to +20D, a 55×45 degree field of view, internal smartphone storage, battery capacity of 3700–4000 mAh depending on model, and uses 12 Mp color CMOS camera sensors (matching the Eyer Retinal Camera). A key novel difference is automated infrared fundus imaging generated during color fundus photography without requiring separate user actions.
IEC 60601-1:2005+A1:2012+A2:2020 (Edition 3.2) for electrical safety, IEC 60601-1-2:2014 (Edition 4.0) for electromagnetic compatibility, ANSI Z80.36:2021 for optical safety, ISO 10940:2009 for fundus camera optical performance, IEC 62304:2015 for software verification and validation, ISO 15004-1:2020 for environmental testing, and ISO 10993-1:2018 and related standards for biocompatibility of the silicone eyecap material.
The Eyer 2 is substantially equivalent to the Eyer Retinal Camera (K221329), Optomed Aurora Camera (K180378), and LipiView II (K152869) because it performs the same fundamental imaging functions—fundus photography and ocular surface imaging—with comparable or superior technical specifications and safety performance. While the Eyer 2 adds infrared fundus imaging capability, this is a minor enhancement generated automatically without additional user intervention. All devices achieve the same clinical outcome: capture and storage of fundus and anterior segment images for documentation and consultation. Performance testing demonstrates compliance with relevant safety, optical, software, and biocompatibility standards equivalent to the predicates, with no new safety or effectiveness concerns introduced.
View the full FDA submission: accessdata.fda.gov