# K011175: W.O.M. Laser U100

- Pathway: 510(k) (Traditional)
- Applicant: W.O.M. World of Medicine GmbH
- Decided: Nov 1, 2001 after 198 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
No predicates in its family tree.
3 later devices descend from it; 2 cite 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)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K023041: W.O.M. Laser U100 (2002), 1 descendant of its own
- K032023: W.O.M. Laser U100PLUS (2003), 0 descendants of its own
- K021686: Laser Fiber GF500 (2002), 0 descendants of its own

Source page: https://510kreport.com/device/K011175
Methodology: https://510kreport.com/methodology