# K211328: Eidon FA, Eidon, Eidon AF, Eidon Uwfl

- Pathway: 510(k) (Special)
- Applicant: Centervue S.P.A.
- Decided: Aug 19, 2021 after 108 days
- Product code: MYC (Ophthalmoscope, Laser, Scanning)
- Device class: 2
- Regulation: 21 CFR 886.1570
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K941234 (1995). 35 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180526: Eidon FA, Centervue S.P.A. (2018) Summary page 4.

## Most influential descendants
- K241931: OcuMet Beacon  (OCUB100) (2025), 0 descendants of its own

## Indications for use
The CenterVue EIDON FA is a confocal scanning ophthalmoscope indicated for color, infrared and auto-fluorescence imaging and fluorescein angiography of a human retina with or without the use of a mydriatic agent.

Source page: https://510kreport.com/device/K211328
Methodology: https://510kreport.com/methodology