# P970019: Healthtronics Lithotron Lihtotripsy System

- Pathway: PMA
- Applicant: Healthtronics Surgical Services, Inc.
- Decided: Jul 21, 1997 after 66 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
No predicates in its family tree.
9 later devices descend from it; 2 cite 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)
- None. PMA decisions do not claim a predicate device.

## Most influential descendants
- K040461: Econolith E3000, Model 3000 (SW-6) (2004), 7 descendants of its own
- K063504: Econolith EM1000 (2007), 6 descendants of its own
- K103217: Lite-Med LM-9200 Elma (2011), 4 descendants of its own
- K142561: LM-9300 ELMA Lithotripter (2015), 1 descendant of its own
- K072788: Storz Modulith Lithotripter SLX-F2-F180 (2007), 1 descendant of its own

Source page: https://510kreport.com/device/P970019
Methodology: https://510kreport.com/methodology