# K030906: Axcel Surgical Light

- Pathway: 510(k) (Special)
- Applicant: Alm
- Decided: Apr 23, 2003 after 30 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: 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). Our reading of the summary gave K382063, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “ALM PrismAlixB (PRX4000 Series) Surgical Light”.

## Cited in the summary but kept off the family tree
- K049651: Angenieux (AX4) Surgical Light. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1.

## Recalls of this device
- Nov 8, 2023 · Class II · Z-0764-2024: A potential for a light system to fall in the operating room.

## Indications for use
ALM S.A. AxcelTM Surgical Lights are intended to be used to provide visible illumination of the surgical area or the patient.

Source page: https://510kreport.com/device/K030906
Methodology: https://510kreport.com/methodology