# K062895: Xenon Brightstar Illumination System, Model 1266.Xiii

- Pathway: 510(k) (Special)
- Applicant: Dutch Ophthalmic Research Center International BV
- Decided: Oct 13, 2006 after 16 days
- Product code: MPA (Endoilluminator)
- Device class: 2
- Regulation: 21 CFR 876.1500
- 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 K963417 (1996). 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)
- K973229: D.O.R.C. Hexon Illumination System, Dutch Ophthalmic USA, Inc. (1997) Summary page 1.

## Indications for use
The Xenon BrightStar Illumination System is intended to provide intraocular illumination in vitreoretinal surgery.

Source page: https://510kreport.com/device/K062895
Methodology: https://510kreport.com/methodology