# K071698: Aurora Led Series Surgical Lights

- Pathway: 510(k) (Traditional)
- Applicant: Skytron, Div. the Kmw Group, Inc.
- Decided: Jul 6, 2007 after 15 days
- Product code: FSY (Light, Surgical, Ceiling Mounted)
- Device class: 2
- Regulation: 21 CFR 878.4580
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K002463 (2000). 1 ancestor in all.
3 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002463: Stellar, Skytron, Div. the Kmw Group, Inc. (2000) Summary page 1.

## Most influential descendants
- K100388: 21ST Century Centurion Exceled and System Two Led Lighting Systems (2010), 1 descendant of its own
- K140812: MI-750 Procedural/Minor Surgical Light (2014), 0 descendants of its own
- K083323: Nuvo Verde Led Lighting System (2009), 0 descendants of its own

## Recalls of this device
- Jul 9, 2024 · Class II · Z-2618-2024: The weld on the light head frame can crack which could lead to problems such as the light head frame sagging, the plastic front face housing cracking, or the light head detaching.
- Jul 9, 2024 · Class II · Z-2620-2024: The weld on the light head frame can crack which could lead to problems such as the light head frame sagging, the plastic front face housing cracking, or the light head detaching.
- Jul 9, 2024 · Class II · Z-2621-2024: The weld on the light head frame can crack which could lead to problems such as the light head frame sagging, the plastic front face housing cracking, or the light head detaching.
- Jul 9, 2024 · Class II · Z-2619-2024: The weld on the light head frame can crack which could lead to problems such as the light head frame sagging, the plastic front face housing cracking, or the light head detaching.

## Indications for use
The SKYTRON Aurora Series surgical light fixture is intended to be used by medical personnel for the purpose of illuminating surgical sites

Source page: https://510kreport.com/device/K071698
Methodology: https://510kreport.com/methodology