# K162778: Portable Slit Lamp Microscope

- Pathway: 510(k) (Traditional)
- Applicant: Suzhou Kangjie Medical, Inc.
- Decided: Jul 21, 2017 after 294 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: 1 generation back to K131711 (2014). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131711: YZ3 Portable Slit Lamp, Suzhou 66 Vision Tech Co., Ltd. (2014) Summary page 4.

## Indications for use
Portable Slit Lamp Microscope Model KJ5S is intended for use in the examination of the anterior and posterior segment of the eye.

Source page: https://510kreport.com/device/K162778
Methodology: https://510kreport.com/methodology