# K213265: Tomey Cornea/Anterior Segment OCT CASIA2

- Pathway: 510(k) (Traditional)
- Applicant: Tomey Corporation
- Decided: Apr 27, 2022 after 209 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: 9 generations back to K012727 (2002). 16 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180660: Avanti, Optovue, Inc. (2018) Summary page 5.

## Most influential descendants
- K250553: Tomey Cornea/Anterior Segment OCT (CASIA2) (2025), 0 descendants of its own

## Indications for use
The Tomey Cornea/Anterior Segment OCT CASIA2 is a non-contact, high resolution tomographic and biomicroscopic device indicated for the in vivo imaging of ocular structures in the anterior segment. The Tomey Cornea/Anterior Segment OCT CASIA2 is indicated as an aid in the visualization of anterior segment findings.

Source page: https://510kreport.com/device/K213265
Methodology: https://510kreport.com/methodology