# K250553: Tomey Cornea/Anterior Segment OCT (CASIA2)

- Pathway: 510(k) (Traditional)
- Applicant: Tomey Corporation
- Decided: Jul 18, 2025 after 143 days
- Product code: OBO (Tomography, Optical Coherence)
- 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 K012727 (2002). 17 ancestors in all.
No later device cites it as a predicate yet.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213265: Tomey Cornea/Anterior Segment OCT CASIA2, Tomey Corporation (2022) Summary page 5.

## Indications for use
CASIA2 is a non-contact, high-resolution tomographic and biomicroscopic device intended for the in vivo imaging and measurement of ocular structures in the anterior segment. CASIA2 measures corneal thickness, anterior chamber depth and lens thickness.

Source page: https://510kreport.com/device/K250553
Methodology: https://510kreport.com/methodology