# K242922: Extracorporeal Shock Wave Lithotripter (U200)

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Wikkon Precision Technologies Co., Ltd.
- Decided: Jun 18, 2025 after 267 days
- Product code: LNS (Lithotriptor, Extracorporeal Shock-Wave, Urological)
- Device class: 2
- Regulation: 21 CFR 876.5990
- 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 P970019 (1997). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103217: Lite-Med LM-9200 Elma, Lite-Med, Inc. (2011) Summary page 5.

## Indications for use
The Extracorporeal Shock Wave Lithotripter, model: U200, is intended to fragment urinary stones in the kidney (renal pelvis and renal calyces) and ureter (upper, middle, and lower ureter).

Source page: https://510kreport.com/device/K242922
Methodology: https://510kreport.com/methodology