510(k) Report

510(k) · Cleared

Cleared

Sonolith I-Move

K111808510(k) TraditionalCleared Aug 1, 201135-day reviewClass II21 CFR 876.5990

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Edap Tms France · LNS Lithotriptor, Extracorporeal Shock-Wave, Urological

Cleared on Aug 1, 2011 as substantially equivalent to K003529 (Edap Technomed, Inc., 2001) and 3 other predicates after a 35-day review. Its family tree reaches back 3 generations to 1984.

Decided
Aug 1, 2011
Review
35 days
Class
Class II
Product code
LNS
Recalls
None
Predicates
4

Its longest line of descent runs back 3 generations to P840008 (1984). 8 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2003: 1 other ancestor2001: 1 other ancestor1991: 1 other ancestor2002: 1 other ancestor1988: 1 other ancestorP840008 · Dornier Lithotripter Compact Transportable (DLCT) · Dornier Medtech America, Inc. · 1984K011873 · Dornier Lithotripter S (Doli S) & Dornier Lithotripter S-XP (Doli S-XP) · Dornier · 2001K083614 · Sonolith I-Sys Lithotriper · Technomed Medical Systems, SA · 20091980198519901995200020052010
Other ancestors, by generation 1 generation back: 3 other ancestors2 generations back: 1 other ancestor3 generations back: 1 other ancestor K083614 · Sonolith I-Sys Lithotriper · Technomed Medical Systems, SA · 2009K011873 · Dornier Lithotripter S (Doli S) & Dornier Lithotripter S-XP (Doli S-XP) · Dornier · 2001P840008 · Dornier Lithotripter Compact Transportable (DLCT) · Dornier Medtech America, Inc. · 19840
  1. Root · 3 generations backP840008 Dornier Lithotripter Compact Transportable (DLCT)Dornier Medtech America, Inc. · 1984
  2. 2 generations backK011873 Dornier Lithotripter S (Doli S) & Dornier Lithotripter S-XP (Doli…Dornier · 2001
  3. 1 generation backK083614 Sonolith I-Sys LithotriperTechnomed Medical Systems, SA · 2009
  4. This deviceK111808 Sonolith I-MoveEdap Tms France · 2011
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3P840008Dornier Lithotripter Compact Transportable (DLCT)Dornier Medtech America, Inc.1984—
−2K011873Dornier Lithotripter S (Doli S) & Dornier Lithotripter S-XP (Doli S-XP)Dornier2001—
−1K083614Sonolith I-Sys LithotriperTechnomed Medical Systems, SA2009—
0 (this device)K111808Sonolith I-MoveEdap Tms France2011—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198810
199110
200110
200210
200310
FIG. 1 — Lineage of K111808, 1984–2011Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in LNS? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new LNS device

  1. #1 K252913 Break Wavescore 15.5 · 7 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (4)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K003529Sonolith Praktis, Endourology Table Praktis
Summary page 1
…Class 11(Special Controls) Product Code MMVZ b) Predicate Device(s) Device # 1 - EDAP TECHNOMED Inc. Sanolith® Praktis. K003529. Device # 2 - EDAP TMS France SA. Sanolith® I-sys treatment module and Sonolith®)I- sys table. K083614. Device # 3 - EDAP Interna…
Edap Technomed, Inc.2001—
*K083614Sonolith I-Sys Lithotriper
Summary page 1
…cate Device(s) Device # 1 - EDAP TECHNOMED Inc. Sanolith® Praktis. K003529. Device # 2 - EDAP TMS France SA. Sanolith® I-sys treatment module and Sonolith®)I- sys table. K083614. Device # 3 - EDAP International Corp. EDAP LT.02 Shack Wave Lithotripter. P880042. Device # 4 - FMVD, LLC.Twinheads®g TH-1 01 IE…
Technomed Medical Systems, SA2009—
*P880042Edap LT.01 Shock Wave Lithotripter
Summary page 1
…# 2 - EDAP TMS France SA. Sanolith® I-sys treatment module and Sonolith®)I- sys table. K083614. Device # 3 - EDAP International Corp. EDAP LT.02 Shack Wave Lithotripter. P880042. Device # 4 - FMVD, LLC.Twinheads®g TH-1 01 IESWIL. K(030346 c) Device Descriotion The SONOLITH® i-move medical d…
Edap International Corp.1991—
*K030346Twinheads TH-101 Extracorporeal Shock Wave Lithotripter
Summary page 1
…Sonolith®)I- sys table. K083614. Device # 3 - EDAP International Corp. EDAP LT.02 Shack Wave Lithotripter. P880042. Device # 4 - FMVD, LLC.Twinheads®g TH-1 01 IESWIL. K(030346 c) Device Descriotion The SONOLITH® i-move medical device is a lithotripter of ESWL type (Extracorporeal Shock Wa…
Fmd, LLC2003—

Also cleared against K003529: 3 other devices →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 27 years and passes through 4 companies; a new generation was cleared every 7.9 years on median.
  • None of the 8 ancestors has a recall.
  • 3 other devices also cite its predicate K003529.

How does its category compare?

All LNS devices

LNS Lithotriptor, Extracorporeal Shock-Wave, Urological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.

FDA decisions per year · LNS

1in 2025

2007: 42008: 22009: 12011: 32012: 32013: 22014: 22015: 22017: 22020: 12021: 12023: 22025: 12026 (partial year): 2
2007high 4 (2007) · low 0 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LNS

111in 2012

2007: 146 days median2011: 307 days median2012: 111 days median
2007high 307 (2011) · low 111 (2012)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LNS

1in 2015

2015: 1
2007high 1 (2015) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LNS

61in 2025

2007: 42008: 102009: 22010: 152011: 212012: 202013: 182014: 212015: 222016: 502017: 542018: 592019: 602020: 382021: 552022: 522023: 862024: 402025: 61
2007high 86 (2023) · low 2 (2009)2025

MAUDE reports naming product code LNS, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007414604
20082—010
20091—02
20100—015
20113307021
20123111020
20132—018
20142—021
20152—122
20160—050
20172—054
20180—059
20190—060
20201—038
20211—055
20220—052
20232—086
20240—040
20251—061
20262—0—

What is it indicated for?

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.

Indications for use as stated in the FDA summary.

Also cleared against K003529

3 other devices cite the same predicate.

  • K083614Sonolith I-Sys LithotriperTechnomed Medical Systems, SA · 2009
  • K030346Twinheads TH-101 Extracorporeal Shock Wave LithotripterFmd, LLC · 2003
  • K013471Delta 2000 Series Extracorporeal LithotripterE.S.W.L. Products, Inc. · 2002

Recent decisions in LNS

The LNS category page

  • K261086Break WaveSonomotion, Inc. · 2026
  • K252913Break WaveSonomotion, Inc. · 2026
  • K242922Extracorporeal Shock Wave Lithotripter (U200)Shenzhen Wikkon Precision Technologies Co., Ltd. · 2025
  • K221903Delta III ProDornier Medtech America, Inc. · 2023
  • K213772LM-9300 Plus LithotripterLite-Med, Inc. · 2023

https://510kreport.com/device/K111808 · printed Nov 6, 2026

Cite this page

510(k) Report. “K111808: Sonolith I-Move.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111808

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026