# K163185: OptiLux LED Illuminator

- Pathway: 510(k) (Traditional)
- Applicant: Isolux, LLC
- Decided: Nov 21, 2016 after 7 days
- Product code: HBI (Illuminator, Fiberoptic, Surgical Field)
- Device class: 2
- Regulation: 21 CFR 878.4580
- 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 lsolux llc OptiLux LED Illuminator is indicated for use in transmitting light for illumination purposes from an LED source via a fiber optic cable and attached to either an endoscope, surgical head light or other tools that contain fiber optic bundles to aid in providing illumination to body cavities during examinations or surgical procedures.

Source page: https://510kreport.com/device/K163185
Methodology: https://510kreport.com/methodology