# K253834: Visuref 600

- Pathway: 510(k) (Traditional)
- Applicant: Carl Zeiss Vision GmbH
- Decided: Mar 18, 2026 after 107 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: 8 generations back to K896095 (1990). 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)
- K162684: SL 220, Carl Zeiss Meditec, AG (2017) Summary page 5.

## Indications for use
VISUREF 600 is a combined autorefractor and keratometer. The device supports the following measurements in eye examination of the anterior eye segment: • Assessment of the opacity of the lens via retro-illumination. • Measurement of tear film break-up time by recording the time between the last complete blink and the first appearance of dark spots in the fluorescein-infilled tear film. • Imaging of the meibomian glands located in the upper and lower eyelids using infrared illumination.

Source page: https://510kreport.com/device/K253834
Methodology: https://510kreport.com/methodology