# K230627: Zilia Ocular FC (ZIL-10002)

- Pathway: 510(k) (Traditional)
- Applicant: Zilia, Inc.
- Decided: Nov 20, 2023 after 259 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: 9 generations back to K941234 (1995). 21 ancestors in all.
No later device cites it as a predicate yet.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182199: NFC-700 non-mydriatic auto fundus camera, Crystalvue Medical Corporation (2019) Summary page 5.

## Indications for use
Zilia Ocular is a non-contact imaging device for capturing, displaying and storing images of the retina under mydriatic conditions. Zilia Ocular is intended for use as an aid to clinicians in the evaluation and documentation of ocular health.

Source page: https://510kreport.com/device/K230627
Methodology: https://510kreport.com/methodology