# K161727: Eyenez Ophthalmic Camera

- Pathway: 510(k) (Traditional)
- Applicant: Eyenez, LLC
- Decided: Oct 4, 2016 after 104 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: 3 generations back to K003376 (2001). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110986: Optomed Smartscope M5 EY3 and M5 ES1, Optomed OY (2011) Summary page 4.

## Indications for use
The Eyenez V200 fundus camera is intended to be used to capture images of the retina of the eye.

Source page: https://510kreport.com/device/K161727
Methodology: https://510kreport.com/methodology