# K153545: Portable Slit Lamp

- Pathway: 510(k) (Traditional)
- Applicant: Shanghai Bolan Optical-Electric Co., Ltd.
- Decided: Jun 22, 2016 after 194 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 K061330 (2006). 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)
- K061330: PSL Portable Slit Lamp, Reichert, Inc. (2006) Summary page 4.

## Indications for use
The BL-5000 portable slit lamp is an AC-powered slit lamp biomicroscope that is intended for use in examining the anterior eye segment, from the corneal epithelium to the posterior capsule. It is used to aid in the diagnosis of diseases or trauma, which affect the structural properties of the anterior segment of the eye

Source page: https://510kreport.com/device/K153545
Methodology: https://510kreport.com/methodology