# K180895: Alleye

- Pathway: 510(k) (Traditional)
- Applicant: Oculocare Medical AG
- Decided: Jun 27, 2018 after 83 days
- Product code: HOQ (Grid, Amsler)
- Device class: 1
- Regulation: 21 CFR 886.1330
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K864318 (1987). 41 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 43 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143211: myVision Track Model 005, Vital Art and Science Incorporated (2015) Summary page 5.

## Most influential descendants
- K203594: EyeCTester (2022), 0 descendants of its own

## Indications for use
The Alleye is a mobile medical software application indicated for the detection and characterization of metamorphopsia, a visual distortion, in patients with age-related macular degeneration (AMD) and as an aid in the monitoring of the progression of this condition in respect of metamorphopsia. It is intended to be used by patients who have the capability to regularly perform a simple self-test at home.

Source page: https://510kreport.com/device/K180895
Methodology: https://510kreport.com/methodology