# K990656: Chromophare D 530 LDR Surgical Light

- Pathway: 510(k) (Traditional)
- Applicant: Berchtold Holding GmbH
- Decided: Jul 20, 1999 after 141 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: 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)
- K974433: Chromophare D 500, Chromophare D 530, Berchtold Holding GmbH (1998) Summary page 1.

## Indications for use
The surgical light, CHROMOPHARE® D 530 LDR, 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/K990656
Methodology: https://510kreport.com/methodology