# K083066: Chromophare E 778 and E 558

- Pathway: 510(k) (Traditional)
- Applicant: Berchtold Holding GmbH
- Decided: Oct 30, 2008 after 15 days
- Product code: FSY (Light, Surgical, Ceiling Mounted)
- 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: 3 generations back to K965130 (1997). 3 ancestors in all.
5 later devices descend from it; 3 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080857: Chromophare E-Series, Berchtold Holding GmbH (2008) Summary page 1.

## Most influential descendants
- K090378: Chromophare E 668 (2009), 2 descendants of its own
- K100388: 21ST Century Centurion Exceled and System Two Led Lighting Systems (2010), 1 descendant of its own
- K142076: Claveguard Freedom Surgical Light (2014), 0 descendants of its own
- K140812: MI-750 Procedural/Minor Surgical Light (2014), 0 descendants of its own
- K120392: Chromophare F 628 and F 528 (2012), 0 descendants of its own

## Indications for use
The surgical lights BERCHTOLD CHROMOPHARE® E 778 and E 558 are 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/K083066
Methodology: https://510kreport.com/methodology