# K991527: Chromophare D500, D530, D650

- Pathway: 510(k) (Special)
- Applicant: Berchtold Holding GmbH
- Decided: May 27, 1999 after 24 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.
No later device cites it as a predicate yet.
0 of 2 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 1.

## Indications for use
The Surgical lights CHROMOPHARE® D500, D530 and D650, 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/K991527
Methodology: https://510kreport.com/methodology