# K231760: HP-Oct (HP-Oct)

- Pathway: 510(k) (Traditional)
- Applicant: Cylite Pty., Ltd.
- Decided: Mar 8, 2024 after 266 days
- Product code: HJO (Biomicroscope, Slit-Lamp, Ac-Powered)
- 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: 10 generations back to K012727 (2002). 26 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181534: Cirrus HD-Oct, Carl Zeiss Meditec, Inc. (2019) Summary page 4.

## Most influential descendants
- K252633: Unity DX (Udx) (2025), 0 descendants of its own

## Indications for use
The HP-OCT™ instrument is a non-contact ophthalmic imaging and analysis device. It is indicated for visualization of the posterior segment of the eye.

Source page: https://510kreport.com/device/K231760
Methodology: https://510kreport.com/methodology