# K053364: Halux Iris Examination and Surgical Lamp

- Pathway: 510(k) (Traditional)
- Applicant: Waldmann Lighting
- Decided: Feb 23, 2006 after 83 days
- Product code: FTD (Lamp, Surgical)
- 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 K042395 (2004). 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)
- K042395: Outpatient Iii Minor Surgery Light, Burton Medical Products Corp. (2004) Summary page 1.

## Indications for use
Halux® Iris is designed to provide the required illumination for surgeries, procedures, and examinations of patients. The Halux® Iris Examination and Surgical Lamp is to be used with various mounting configurations in operating rooms, examination rooms, emergency rooms and all other health care facilities where the need for additional illumination exists.

Source page: https://510kreport.com/device/K053364
Methodology: https://510kreport.com/methodology