# K163564: Slit Lamp SL-2000

- Pathway: 510(k) (Traditional)
- Applicant: Nidek Co., Ltd.
- Decided: May 19, 2017 after 151 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). 22 ancestors in all.
No later device cites it as a predicate yet.
0 of 23 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 5.
- K140451: Keeler Slit Lamp H-Series Digital (Halogen Bulb Option), Keeler Slit Lamp H-Series Digital (Led Option), Keeler Limited (2014) Summary page 5.

## Indications for use
The SLIT LAMP SL-2000 is intended for use in eye examination of the anterior eye segment, from the corneal epithelium to the posterior capsule. This device is used to aid in the diagnosis of diseases or trauma which affect the structural properties of the anterior eye segment.

Source page: https://510kreport.com/device/K163564
Methodology: https://510kreport.com/methodology