# K142561: LM-9300 ELMA Lithotripter

- Pathway: 510(k) (Abbreviated)
- Applicant: Lite-Med, Inc.
- Decided: Mar 20, 2015 after 190 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.
1 later device descends from it; 1 cites it directly.
0 of 10 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 4.
- K002929: Dornier Compact Alpha Lithotripter, Dornier Medtech America, Inc. (2001) Summary page 4.
- K070665: Lithoskop, Siemens Medical Solutions USA, Inc. (2008) Summary page 4.

## Most influential descendants
- K201001: Modulith SLX-F2 (2021), 0 descendants of its own

## Indications for use
The Lite-Med LM-9300 ELMA Lithotripter is indicated for fragmentation of kidney stones such as renal calyx stones and renal pelvic stones and for upper, middle and lower ureteral stones by extracorporeal shock wave lithotripsy (ESWL).

Source page: https://510kreport.com/device/K142561
Methodology: https://510kreport.com/methodology