# K965130: Chromophare

- Pathway: 510(k) (Traditional)
- Applicant: Berchtold Holding GmbH
- Decided: Jul 14, 1997 after 203 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
No predicates in its family tree.
27 later devices descend from it; 4 cite it directly.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K024132: Chromophare X 65 (2003), 23 descendants of its own
- K061317: ILED (2006), 16 descendants of its own
- K072072: Harmony Led-1 Surgical Lighting System (2007), 10 descendants of its own
- K080857: Chromophare E-Series (2008), 6 descendants of its own
- K083066: Chromophare E 778 and E 558 (2008), 5 descendants of its own

## Indications for use
The Surgical light, CHROMOPHARE® D-650. is intended to illuminate locally the operating site on the patient's body with a high light intensity. “cold” light.

Source page: https://510kreport.com/device/K965130
Methodology: https://510kreport.com/methodology