# K042382: Dual Led Lite Engine with Illumination Led Cable Coupled to a Led Lite Head

- Pathway: 510(k) (Traditional)
- Applicant: Med-General Technologies, LLC
- Decided: Nov 30, 2004 after 90 days
- Product code: FSY (Light, Surgical, Ceiling Mounted)
- 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.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices 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.

## Most influential descendants
- K060802: Visum Led Surgical Lighting System (2006), 1 descendant of its own
- K132747: Visum Blade Led Surgical Lighting System (2013), 0 descendants of its own

## Indications for use
Illumination in body cavities during examinations or minimal invasive surgical procedures.

Source page: https://510kreport.com/device/K042382
Methodology: https://510kreport.com/methodology