# K252633: Unity DX (Udx)

- Pathway: 510(k) (Traditional)
- Applicant: Cylite Pty., Ltd.
- Decided: Dec 23, 2025 after 125 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: 11 generations back to K896095 (1990). 68 ancestors in all.
No later device cites it as a predicate yet.
0 of 69 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K231760: HP-Oct (HP-Oct), Cylite Pty., Ltd. (2024) Summary page 6.
- K173771: IOLMaster 700, Carl Zeiss Meditec, AG (2018) Summary page 6.

## Indications for use
The Unity DX instrument is a non-contact ophthalmic imaging and analysis device. It is indicated for visualization of anterior and posterior ocular structures and measurement of anterior segment and biometric parameters including: *Axial Length * Anterior Chamber Depth * Central Corneal Thickness * Lens Thickness The Reference Image functionality is intended for use as an ocular image capture tool.

Source page: https://510kreport.com/device/K252633
Methodology: https://510kreport.com/methodology