# K252348: Tomey Optical Biometer OA-2000 (OA-2000)

- Pathway: 510(k) (Traditional)
- Applicant: Tomey Corporation
- Decided: Dec 18, 2025 after 142 days
- Product code: MXK (Device, Analysis, Anterior Segment)
- Device class: 2
- Regulation: 21 CFR 886.1850
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K955442 (1996). 19 ancestors in all.
No later device cites it as a predicate yet.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082891: Lenstar, Model LS900, Haag-Streit AG (2009) Summary page 5.

## Indications for use
The OA-2000 is a non-invasive, non-contact biometer intended for obtaining ocular measurements to assist in the determination of the appropriate power of an intraocular lens for implantation. The OA-2000 measures: Axial length, corneal thickness, anterior chamber depth and lens thickness.

Source page: https://510kreport.com/device/K252348
Methodology: https://510kreport.com/methodology