# K131589: Keeler Slit Lamp H-Series

- Pathway: 510(k) (Abbreviated)
- Applicant: Keeler, Ltd.
- Decided: Jun 27, 2013 after 27 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: 2 generations back to K982057 (1998). 2 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100202: Slit Lamp BO 900, BQ 900, BP900, Haag-Streit AG (2010) Summary page 1.

## Most influential descendants
- K140451: Keeler Slit Lamp H-Series Digital (Halogen Bulb Option), Keeler Slit Lamp H-Series Digital (Led Option) (2014), 2 descendants of its own
- K171877: SLM-1ER, SLM-2ER, SLM-3ER (2017), 0 descendants of its own
- K163564: Slit Lamp SL-2000 (2017), 0 descendants of its own
- K151394: Keeler Slit Lamp (2015), 0 descendants of its own

## Indications for use
The Keeler Slit Lamp is an AC-powered Slit lamp biomicroscope 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 authorised healthcare professionals.

Source page: https://510kreport.com/device/K131589
Methodology: https://510kreport.com/methodology