# K040015: Modification to Prismalix Surgical Light

- Pathway: 510(k) (Special)
- Applicant: Alm S.A.
- Decided: Jan 21, 2004 after 16 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: 2 generations back to K860739 (1986). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982063: Alm Prismalix (PRX) Surgical Light, Alm Surgical Equipment, Inc. (1998) Summary page 1.

## Indications for use
ALM S.A. PrismAlix ® (PRX) Surgical Lights with Energix Tm Power Supply are intended to be used to provide visible illumination of the surgical area or the patient. The Energix Tm Power Supply is intended for use with surgical light systems.

Source page: https://510kreport.com/device/K040015
Methodology: https://510kreport.com/methodology