# K023041: W.O.M. Laser U100

- Pathway: 510(k) (Traditional)
- Applicant: W.O.M. World of Medicine AG
- Decided: Dec 11, 2002 after 90 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: 1 generation back to K901723 (1990). 2 ancestors in all.
1 later device descends from it; 1 cites 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)
- K011175: W.O.M. Laser U100, W.O.M. World of Medicine GmbH (2001)
- K901723: MDL-2000 Lasertripter, Candela Laser Corp. (1990) Summary page 1.

## Most influential descendants
- K032023: W.O.M. Laser U100PLUS (2003), 0 descendants of its own

## Indications for use
The W.O.M. Laser UlOO is indicated for use in the contact mode to fiagment urinary stones (kidney, ureter, bladder) and biliary stones in closed surgical procedures.

Source page: https://510kreport.com/device/K023041
Methodology: https://510kreport.com/methodology