# K181444: Clarus

- Pathway: 510(k) (Traditional)
- Applicant: Carl Zeiss Meditec, Inc.
- Decided: Jan 10, 2019 after 223 days
- Product code: QER (Camera, Ophthalmic, Slit-Scanning)
- Device class: 2
- Regulation: 21 CFR 886.1120
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K941234 (1995). 6 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052268: Visucam Pro NM, Carl Zeiss Meditec, AG (2005) Summary page 4.

## Most influential descendants
- K191194: Clarus (2019), 1 descendant of its own
- K243878: Clarus (700) (2025), 0 descendants of its own

## Indications for use
The CLARUS 500 ophthalmic camera is indicated to capture, display, annotate and store images to aid in the diagnosis and monitoring of diseases and disorders occurring in the retina, ocular surface and visible adnexa. It provides true color and autofluorescence imaging modes for stereo, widefield, ultra-widefield, and montage fields of view.

Source page: https://510kreport.com/device/K181444
Methodology: https://510kreport.com/methodology