# K100388: 21ST Century Centurion Exceled and System Two Led Lighting Systems

- Pathway: 510(k) (Traditional)
- Applicant: Medical Illumination International, Inc.
- Decided: Jun 22, 2010 after 126 days
- Product code: FST (Light, Surgical, Fiberoptic)
- 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
Longest line of descent: 4 generations back to K965130 (1997). 12 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083066: Chromophare E 778 and E 558, Berchtold Holding GmbH (2008) Summary page 1.
- K070442: Powerled Surgical Light System, Maquet S.A. (2007) Summary page 1.
- K071698: Aurora Led Series Surgical Lights, Skytron, Div. the Kmw Group, Inc. (2007) Summary page 1.
- K072072: Harmony Led-1 Surgical Lighting System, STERIS Corporation (2007) Summary page 1.
- K061317: ILED, Trumpf Kreuzer Medizin Systeme GmbH + Co.Kg (2006) Summary page 1.

## Most influential descendants
- K140812: MI-750 Procedural/Minor Surgical Light (2014), 0 descendants of its own

## Indications for use
The System Two LED surgical Lighting System is an AC powered device which provides a focusable field of illumination for general examination and surgery. It can consist of any combination of the 3 lights (D1, D2, D3) listed below. All 3 models will have 5-level dimming and beam size (8"-12") adjustments. D1 = small minor surgical light / satellite D2 = large minor surgical light D3 = major surgical light

Source page: https://510kreport.com/device/K100388
Methodology: https://510kreport.com/methodology