# K070442: Powerled Surgical Light System

- Pathway: 510(k) (Special)
- Applicant: Maquet S.A.
- Decided: Mar 16, 2007 after 29 days
- Product code: FSY (Light, Surgical, Ceiling Mounted)
- Device class: 2
- Regulation: 21 CFR 878.4580
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K904965 (1991). 2 ancestors in all.
14 later devices descend from it; 7 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040735: Alm X'ten (X10) Surgical Light System, Alm S.A. (2004) Summary page 1.

## Most influential descendants
- K072072: Harmony Led-1 Surgical Lighting System (2007), 10 descendants of its own
- K093009: Mach Led SC (2010), 4 descendants of its own
- K113679: Lucea Led Surgical Light System (2012), 2 descendants of its own
- K132307: Vida Led Surgical Lighting System (2013), 1 descendant of its own
- K100388: 21ST Century Centurion Exceled and System Two Led Lighting Systems (2010), 1 descendant of its own

## Recalls of this device
- Aug 7, 2026 · Class II · Z-3224-2026: The potential for the device to detach at the junction between the spring arm and suspension arm and fall causing potential injury.
- Nov 8, 2023 · Class II · Z-0763-2024: A potential for a light system to fall in the operating room.
- May 29, 2015 · Class II · Z-1990-2015: Maquet Suspension Arms used with PowerLED/X-TEN/Volista Surgical Light Systems may grind at the junction of the suspension arms which can cause paint chips or particles to fall into the surgical field

## Indications for use
MAQUET POWERLED™ Surgical Light Systems are intended to be used to provide visible illumination of the surgical area or the patient. An "LED inside" feature is available which produces lower intensity levels of ambient light, intended for minimally invasive surgery, procedures and examination. An added optional patented automatic head recognition system feature is available to reduce the heat projected on to the surgeon's head, and to compensate for loss of illumination due to an obstacle in front of the cupola.

Source page: https://510kreport.com/device/K070442
Methodology: https://510kreport.com/methodology