# K100439: Mediworks Slit Lamp

- Pathway: 510(k) (Traditional)
- Applicant: Shanghai Mediworks Precision Instruments Co., Ltd.
- Decided: Jul 16, 2010 after 149 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The MediWorks Model S280, S280S, S350, S350S Slit Lamps are AC-powered slit lamp biomicroscopes intended for use in eye examination of the anterior eye segment, from the cornea epithelium to the posterior capsule. They are 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/K100439
Methodology: https://510kreport.com/methodology