# K974433: Chromophare D 500, Chromophare D 530

- Pathway: 510(k) (Traditional)
- Applicant: Berchtold Holding GmbH
- Decided: Feb 20, 1998 after 88 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: 1 generation back to K965130 (1997). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K965130: Chromophare, Berchtold Holding GmbH (1997) Summary page 2.

## Most influential descendants
- K990656: Chromophare D 530 LDR Surgical Light (1999), 0 descendants of its own

## Indications for use
The surgical lights, CHROMOPHARE® D 500 and D 530, 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/K974433
Methodology: https://510kreport.com/methodology