# K251353: Eyer 2

- Pathway: 510(k) (Traditional)
- Applicant: Phelcom Technologies
- Decided: Jan 16, 2026 after 261 days
- Product code: HKI (Camera, Ophthalmic, Ac-Powered)
- Device class: 2
- Regulation: 21 CFR 886.1120
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K003376 (2001). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K221329: Eyer Retinal Camera NM-STD, Phelcom Technologies (2023) Summary page 5.
- K180378: Optomed Aurora Camera with Aurora Retinal Module and Aurora Anterior Module, Optomed OY (2018) Summary page 6.

## Indications for use
Eyer 2® is a portable fundus camera for use with the Samsung Galaxy S21, Galaxy S22, or Galaxy S23 smartphone to capture fundus images. It can be coupled to a front module for imaging of the surface of the eye and the surrounding areas, , including the meibomian glands.

Source page: https://510kreport.com/device/K251353
Methodology: https://510kreport.com/methodology