# K241931: OcuMet Beacon  (OCUB100)

- Pathway: 510(k) (Traditional)
- Applicant: Ocusciences, Inc.
- Decided: Apr 22, 2025 after 295 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: 10 generations back to K941234 (1995). 36 ancestors in all.
No later device cites it as a predicate yet.
0 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211328: Eidon FA, Eidon, Eidon AF, Eidon Uwfl, Centervue S.P.A. (2021) Summary page 5.

## Indications for use
OcuMet Beacon is a confocal scanning ophthalmoscope indicated for infrared (IR) and autofluorescence (AF) imaging of a human retina with or without the use of a mydriatic agent.

Source page: https://510kreport.com/device/K241931
Methodology: https://510kreport.com/methodology