# K042395: Outpatient Iii Minor Surgery Light

- Pathway: 510(k) (Traditional)
- Applicant: Burton Medical Products Corp.
- Decided: Dec 1, 2004 after 90 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
No predicates in its family tree.
3 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K101537: Aim 200, Major Surgical Light (2010), 1 descendant of its own
- K132747: Visum Blade Led Surgical Lighting System (2013), 0 descendants of its own
- K053364: Halux Iris Examination and Surgical Lamp (2006), 0 descendants of its own

## Indications for use
The Outpatient® III Minor Surgery Light is designed to provide the required illumination for surgeries, procedures, and examinations of patients. The Outpatient®III light 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/K042395
Methodology: https://510kreport.com/methodology