# K063333: M3

- Pathway: 510(k) (Traditional)
- Applicant: Mavig GmbH
- Decided: Nov 21, 2006 after 15 days
- Product code: FSY (Light, Surgical, Ceiling Mounted)
- Device class: 2
- Regulation: 21 CFR 878.4580
- 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: 2 generations back to K965130 (1997). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K024132: Chromophare X 65, Berchtold Holding GmbH (2003) Summary page 2.

## Recalls of this device
- Oct 10, 2012 · Class II · Z-0515-2013: A particular component may not have been fitted during the installation of some MAVIG PORTEGRA 2 systems.

## Indications for use
The surgical light M3 is intended to illuminate locally the operating site on the patient's body with a high intensity, shadow-free, "cold' light.

Source page: https://510kreport.com/device/K063333
Methodology: https://510kreport.com/methodology