# K982063: Alm Prismalix (PRX) Surgical Light

- Pathway: 510(k) (Traditional)
- Applicant: Alm Surgical Equipment, Inc.
- Decided: Sep 22, 1998 after 102 days
- Product code: FSY (Light, Surgical, Ceiling Mounted)
- Device class: 2
- Regulation: 21 CFR 878.4580
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K860739 (1986). 4 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K882613: Alm Surgical Lamps, Alm Surgical Equipment, Inc. (1988) Summary page 1.
- K922836: Chromophare, Berchtold Holding GmbH (1992) Summary page 2.
- K943288: Amsco SQ240 Surgical Light, American Sterilizer Co. (1994) Summary page 2.
- K860739: Chick Surigical Light, Professional Medical Products, Inc. (1986) Summary page 3.

## Most influential descendants
- K040015: Modification to Prismalix Surgical Light (2004), 0 descendants of its own
- K030906: Axcel Surgical Light (2003), 0 descendants of its own

## Recalls of this device
- Nov 8, 2023 · Class II · Z-0767-2024: A potential for a light system to fall in the operating room.

## Indications for use
ALM Prismalix (PRX) Surgical Lights are intended to provide visible illumination for the surgical field or for the examination of the patient. PRX is designed to eliminate shadows, reduce reflected heat, and illuminate surgical incisions of all depths during surgical procedures. Use is by surgeons and other medical care givers. The ALM PRX Surgical Lights will be used in indications which are the same as indications for other surgical lights currently offered for commercial distribution in the United States.

Source page: https://510kreport.com/device/K982063
Methodology: https://510kreport.com/methodology