# K100500: PSL Classic Slit Lamp

- Pathway: 510(k) (Traditional)
- Applicant: Keeler Instruments, Inc.
- Decided: Mar 9, 2010 after 15 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 K954782 (1995). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063640: Kowa SL-15, Kowa Co., Ltd. (2006) Summary page 2.

## Indications for use
Keeler PSL Classic Slit Lamp is an AC-powered Slit lamp biomicroscope. It 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.

Source page: https://510kreport.com/device/K100500
Methodology: https://510kreport.com/methodology