# K151394: Keeler Slit Lamp

- Pathway: 510(k) (Traditional)
- Applicant: Keeler Limited
- Decided: Sep 10, 2015 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: 4 generations back to K982057 (1998). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131589: Keeler Slit Lamp H-Series, Keeler, Ltd. (2013) Summary page 4.
- K140451: Keeler Slit Lamp H-Series Digital (Halogen Bulb Option), Keeler Slit Lamp H-Series Digital (Led Option), Keeler Limited (2014) Summary page 4.

## Indications for use
The Keeler Slit Lamp Z-series and Keeler Slit Lamp Z-series Digital are AC-powered Slit lamp bio-microscopes and is intended for use in eye examination of the anterior eye segment, from the cornea epithelium to the posterior capsule. It is used to aid in the diagnosis of diseases or trauma which affects the structural properties of the anterior eye segment This device is intended to be used only by suitably trained and authorized healthcare professionals

Source page: https://510kreport.com/device/K151394
Methodology: https://510kreport.com/methodology