# K113679: Lucea Led Surgical Light System

- Pathway: 510(k) (Special)
- Applicant: Maquet S.A.S.
- Decided: Jan 12, 2012 after 29 days
- Product code: NTN (Led Light Source)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K904965 (1991). 5 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070442: Powerled Surgical Light System, Maquet S.A. (2007) Summary page 1.
- K954169: Hanaulux Blue 30 & 80, Heraeus Med GmbH (1996) Summary page 1.
- K970886: Hanaulux Blue 80 Hospital, Heraeus Med GmbH (1997) Summary page 1.

## Most influential descendants
- K140812: MI-750 Procedural/Minor Surgical Light (2014), 0 descendants of its own
- K130513: Volista 400; Volista 600 (2013), 0 descendants of its own

## Recalls of this device
- Nov 8, 2023 · Class II · Z-0759-2024: A potential for a light system to fall in the operating room.

## Indications for use
MAQUET LUCEA LED® Surgical Light Systems are intended to be used to provide visible illumination of the surgical area or the patient during surgical operations, diagnostics and treatment.

Source page: https://510kreport.com/device/K113679
Methodology: https://510kreport.com/methodology