# K032023: W.O.M. Laser U100PLUS

- Pathway: 510(k) (Traditional)
- Applicant: W.O.M. World of Medicine AG
- Decided: Oct 1, 2003 after 93 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 K964760 (1997). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023041: W.O.M. Laser U100, W.O.M. World of Medicine AG (2002) Summary page 3.
- K984591: Dornier Medilas H/2, Dornier Surgical Products, Inc. (1999) Summary page 2.

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

Source page: https://510kreport.com/device/K032023
Methodology: https://510kreport.com/methodology