# K024132: Chromophare X 65

- Pathway: 510(k) (Special)
- Applicant: Berchtold Holding GmbH
- Decided: Mar 21, 2003 after 95 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.
23 later devices descend from it; 3 cite it directly.
0 of 25 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.

## Most influential descendants
- 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
- K093009: Mach Led SC (2010), 4 descendants of its own

## Indications for use
The surgical light BERCHTOLD CHROMOPHARE'* X65 is intended to illuminate tocaily the operating site on the patient's body with a high intensity, shadow free, "cold" light.

Source page: https://510kreport.com/device/K024132
Methodology: https://510kreport.com/methodology