# K992090: Millennium Gold

- Pathway: 510(k) (Traditional)
- Applicant: Skytron, Div. the Kmw Group, Inc.
- Decided: Sep 8, 1999 after 79 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.
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 Millennium Gold Series Surgical light is intended to be used by medical personnel for the purpose of illuminating surgical sites.

Source page: https://510kreport.com/device/K992090
Methodology: https://510kreport.com/methodology