# K041943: Xtrac XL, Model AL8000

- Pathway: 510(k) (Traditional)
- Applicant: Photo Medex, Inc.
- Decided: Oct 14, 2004 after 87 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K885026 (1989). 9 ancestors in all.
11 later devices descend from it; 2 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992914: Excimer Laser Phototherapy System, AL7000, Acculase, Inc. (2000) Summary page 1.
- K003705: Xtrac Excimer Laser System, Model AL7000, Photo Medex, Inc. (2001) Summary page 1.
- K011382: Xtrac Excimer Laser System, Model AL 7000, Photo Medex, Inc. (2001) Summary page 1.
- K020847: Xtrac Excimer Laser System, Model AL7000, Photo Medex, Inc. (2002) Summary page 1.
- K031451: Xtracxl Plus Excimer Laser System, Model AL7000, Photo Medex, Inc. (2003) Summary page 1.

## Most influential descendants
- K073659: Xtrac Ultra 2, Model AL10000 (2008), 7 descendants of its own
- K103540: Psoria-Light (2011), 3 descendants of its own
- K062963: Pharos Excimer Laser System, Model EX-308 (2007), 3 descendants of its own
- K192411: Psoria-Shield AURORA (2020), 2 descendants of its own
- K172639: PALLAS 308/311 Solid-State UV Laser System (2017), 2 descendants of its own

## Indications for use
UVB Phototherapy for psoriasis, vitiligo, atopic dermatitis, and leukoderma

Source page: https://510kreport.com/device/K041943
Methodology: https://510kreport.com/methodology