# K111808: Sonolith I-Move

- Pathway: 510(k) (Traditional)
- Applicant: Edap Tms France
- Decided: Aug 1, 2011 after 35 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 P840008 (1984). 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)
- K003529: Sonolith Praktis, Endourology Table Praktis, Edap Technomed, Inc. (2001) Summary page 1.
- K083614: Sonolith I-Sys Lithotriper, Technomed Medical Systems, SA (2009) Summary page 1.
- P880042: Edap LT.01 Shock Wave Lithotripter, Edap International Corp. (1991) Summary page 1.
- K030346: Twinheads TH-101 Extracorporeal Shock Wave Lithotripter, Fmd, LLC (2003) Summary page 1.

## Indications for use
The Sonolith® i-move is intended to fragment stones in the kidney (renal pelvis and renal calyces) and the ureter (upper, middle and lower ureter). The ESWLLS table is intended for extracorporeal shock wave lithotripsy (ESWL) procedures in conjunction with the diagnostic and therapeutic module of the platform. The TEU table is intended for urological diagnostics, endourological procedures and extracorporeal shock wave lithotripsy (ESWL) procedures in conjunction with the diagnostic and therapeutic module of the platform.

Source page: https://510kreport.com/device/K111808
Methodology: https://510kreport.com/methodology