# K021686: Laser Fiber GF500

- Pathway: 510(k) (Traditional)
- Applicant: W.O.M. World of Medicine AG
- Decided: Aug 20, 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 K994010 (1999). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 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)
- K994010: Innovaquartz General Shape Laser Fiber, Innovaquartz (1999) Summary page 1.

## Indications for use
The Laser Fiber GF500 is intended to be used as a fiber optic delivery system in conjunction with the W.O.M. Laser UlOO during lithotripsy procedures in the contact mode.

Source page: https://510kreport.com/device/K021686
Methodology: https://510kreport.com/methodology