# K103217: Lite-Med LM-9200 Elma

- Pathway: 510(k) (Abbreviated)
- Applicant: Lite-Med, Inc.
- Decided: Sep 28, 2011 after 331 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: 3 generations back to P970019 (1997). 7 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002929: Dornier Compact Alpha Lithotripter, Dornier Medtech America, Inc. (2001) Summary page 1.
- K070665: Lithoskop, Siemens Medical Solutions USA, Inc. (2008)
- K063504: Econolith EM1000, Medispec, Ltd. (2007) Summary page 1.

## Most influential descendants
- K142561: LM-9300 ELMA Lithotripter (2015), 1 descendant of its own
- K242922: Extracorporeal Shock Wave Lithotripter (U200) (2025), 0 descendants of its own
- K201001: Modulith SLX-F2 (2021), 0 descendants of its own
- K131721: Extracorporeal Shock Wave Lithotripter, Comed Asadal-M1 (2014), 0 descendants of its own

## Indications for use
The Lite-Med LM-9200ELMA 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.

Source page: https://510kreport.com/device/K103217
Methodology: https://510kreport.com/methodology