# K161607: Visulux

- Pathway: 510(k) (Traditional)
- Applicant: Carl Zeiss Meditec, AG
- Decided: Feb 23, 2017 after 258 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: 7 generations back to K896095 (1990). 18 ancestors in all.
No later device cites it as a predicate yet.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133476: Slit Lamps with SL Cam 5.0 Digital Imaging Solution, Carl Zeiss Meditec, AG (2014) Summary page 4.

## Indications for use
The fiber slit illuminator is indicated for use as an alternative illumination system to the surgical microscope in ophthalmic microsurgery for procedures on the anterior and posterior segments of the eye. The fiber slit illuminator is not equipped with a light source, but uses the light transferred from the microscope by a light guide.

Source page: https://510kreport.com/device/K161607
Methodology: https://510kreport.com/methodology