LNS · Lithotriptor, Extracorporeal Shock-Wave, Urological
Gastroenterology, Urology · 21 CFR 876.5990 · Class 2
Overview
| Product Code | LNS |
|---|---|
| Device Name | Lithotriptor, Extracorporeal Shock-Wave, Urological |
| Regulation | 21 CFR 876.5990 |
| Device Class | Class 2 |
| Review Panel | Gastroenterology, Urology |
Identification
An extracorporeal shock wave lithotripter is a device that focuses ultrasonic shock waves into the body to noninvasively fragment urinary calculi within the kidney or ureter. The primary components of the device are a shock wave generator, high voltage generator, control console, imaging/localization system, and patient table. Prior to treatment, the urinary stone is targeted using either an integral or stand-alone localization/imaging system. Shock waves are typically generated using electrostatic spark discharge (spark gap), electromagnetically repelled membranes, or piezoelectric crystal arrays, and focused onto the stone with either a specially designed reflector, dish, or acoustic lens. The shock waves are created under water within the shock wave generator, and are transferred to the patient's body using an appropriate acoustic interface. After the stone has been fragmented by the focused shock waves, the fragments pass out of the body with the patient's urine.
Classification Rationale
Class II (special controls) (FDA guidance document: “Guidance for the Content of Premarket Notifications (510(k)'s) for Extracorporeal Shock Wave Lithotripters Indicated for the Fragmentation of Kidney and Ureteral Calculi.”)
Special Controls
*Classification.* Class II (special controls) (FDA guidance document: “Guidance for the Content of Premarket Notifications (510(k)'s) for Extracorporeal Shock Wave Lithotripters Indicated for the Fragmentation of Kidney and Ureteral Calculi.”)
Cleared Devices (68)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K252913 | Break Wave | Sonomotion, Inc. | Jan 12, 2026 | SESE |
| K242922 | Extracorporeal Shock Wave Lithotripter (U200) | Shenzhen Wikkon Precision Technologies Co., Ltd. | Jun 18, 2025 | SESE |
| K221903 | Delta III Pro | Dornier Medtech America, Inc. | Feb 22, 2023 | SESE |
| K213772 | LM-9300 Plus Lithotripter | Lite-Med, Inc. | Jan 19, 2023 | SESE |
| K201001 | Modulith SLX-F2 | Karl Storz Endoscopy America | Mar 30, 2021 | SESE |
| K201074 | Delta III Lithotripter | Dornier Medtech America, Inc. | Sep 3, 2020 | SESE |
| K172084 | Delta III Lithotripter | Dornier Medtech America, Inc. | Aug 8, 2017 | SESE |
| K170122 | Delta III Lithotripter | Dornier Medtech America | Jun 28, 2017 | SESE |
| K151298 | Gemini XXP-HP | Dornier Medtech America | Jul 30, 2015 | SESE |
| K142561 | LM-9300 ELMA Lithotripter | Lite-Med, Inc. | Mar 20, 2015 | SESE |
| K131817 | EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER | Osmunda Medical Device Consulting Co., Ltd. | Sep 26, 2014 | SESE |
| K131721 | EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER, COMED ASADAL-M1 | Comed Medical Systems Co., Ltd. | Jul 22, 2014 | SESE |
| K132672 | EXTRA CORPOREAL SHOCKWAVE LITHOTRIPTER | Dornier Medtech America | Sep 23, 2013 | SESE |
| K130729 | EXTRA CORPOREAL SHOCKWAVE LITHOTRIPTER | Dornier Medtech Systems | May 14, 2013 | SESE |
| K121656 | GEMINI LITHOTRIPTER | Dornier Medtech America, Inc. | Sep 24, 2012 | SESE |
| K120769 | MODULTH SLK | KARL STORZ Endoscopy-America, Inc. | Jun 12, 2012 | SESE |
| K111947 | DUET MAGNA | Direx Systems Corp. | Mar 1, 2012 | SESE |
| K103217 | LITE-MED LM-9200 ELMA | Lite-Med, Inc. | Sep 28, 2011 | SESE |
| K111808 | SONOLITH I-MOVE | Edap Tms France | Aug 1, 2011 | SESE |
| K101482 | EM-9000 | Elite Medical, Inc. | Mar 31, 2011 | SESE |
| K083614 | SONOLITH I-SYS LITHOTRIPER | Technomed Medical Systems, SA | Jul 27, 2009 | SESE |
| K072538 | PIEZOLITH 3000 TRIPLE-FOCUS LITHOTRIPTER | United Medical Systems, Inc. | Jan 30, 2008 | SESE |
| K070665 | LITHOSKOP | Siemens Medical Solutions USA, Inc. | Jan 4, 2008 | SESE |
| K072788 | STORZ MODULITH LITHOTRIPTER SLX-F2-F180 | KARL STORZ Endoscopy-America, Inc. | Dec 26, 2007 | SESE |
| K070799 | MODULARIS VARIOSTAR | Siemens Medical Solutions USA, Inc. | Nov 1, 2007 | SESE |
| K070579 | STORZ SLX-F2 STORM TOUCH | KARL STORZ Endoscopy-America, Inc. | Aug 30, 2007 | SESE |
| K063504 | ECONOLITH EM1000 | Medispec, Ltd. | Mar 9, 2007 | SESE |
| K061350 | LITHODIAMOND ULTRA | Pck Electronic Industry & Trade Co., Ltd. | Dec 22, 2006 | SESE |
| K062081 | LITHOGOLD | Tissue Regeneration Technologies, Inc. | Nov 2, 2006 | SESE |
| K062147 | INTEGRA SL | Direx Systems Corp. | Oct 20, 2006 | SESE |
| K053640 | INTEGRA | Direx Systems Corp. | Mar 1, 2006 | SESE |
| K050091 | TRIPTER-X1 COMPACT DUET SP (SEPARATED PULSE) | Direx Systems Corp. | Mar 16, 2005 | SESE |
| K042427 | GENESTONE EXEL (XL) EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER | Genemed, Inc. | Dec 3, 2004 | SESE |
| K042561 | TWINHEADS TH-103 EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER | Fmd, LLC | Oct 12, 2004 | SESE |
| K040476 | STORZ MODULITH, MODEL SLX-F2 | KARL STORZ Endoscopy-America, Inc. | Aug 26, 2004 | SESE |
| K040741 | ULTRASOUND LOCALIZATION SYSTEM ULS 0142 | Hmt High Medical Technologies AG | Aug 19, 2004 | SESE |
| K041582 | MODIFICATION TO TRIPTER X-1 COMPACT DUET | Direx Systems Corp. | Jul 7, 2004 | SESE |
| K040461 | ECONOLITH E3000, MODEL 3000 (SW-6) | Medispec, Ltd. | May 25, 2004 | SESE |
| K040470 | TRIPTER X-1 COMPACT | Direx Systems Corp. | Apr 28, 2004 | SESE |
| K032958 | PIEZOLITH 3000 LITHOTRIPTER, MODEL 3000 | United Medical Systems, Inc. | Feb 17, 2004 | SESE |
| K030346 | TWINHEADS TH-101 EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER | Fmd, LLC | May 2, 2003 | SESE |
| K023535 | TRIPTER X-1 COMPACT DUET | Direx Systems Corp. | Jan 17, 2003 | SESE |
| K021775 | LTFS230 | Healthtronics, Inc. | Dec 23, 2002 | SESE |
| K011700 | MODULITH SLK LITHOTRIPTER | Karl Storz Endoscopy | Aug 16, 2002 | SESE |
| K013471 | DELTA 2000 SERIES EXTRACORPOREAL LITHOTRIPTER | E.S.W.L. Products, Inc. | Apr 29, 2002 | SESE |
| K011106 | STONELITH, MODEL V5 | Pck Electronic Industry and Trade Co, Ltd. | Feb 11, 2002 | SESE |
| K012785 | TWINTRODE ELC 134 ELECTRODE | Healthtronics Surgical Services, Inc. | Nov 16, 2001 | SESE |
| K012482 | STORZ MODULITH SLK LITHOTRIPTER WITH MULTIVIEW OPTION | KARL STORZ Endoscopy-America, Inc. | Oct 16, 2001 | SESE |
| K011873 | DORNIER LITHOTRIPTER S(DOLI S) & DORNIER LITHOTRIPTER S-XP (DOLI S-XP) | Dornier | Aug 31, 2001 | SESE |
| K011773 | DORNIER LITHOTRIPTER 140(DOLI 140) | Dornier | Jun 22, 2001 | SESE |
| K002801 | MPS M ELECTRODE | Medical Physics and Services, Inc. | May 4, 2001 | SESU |
| K002929 | DORNIER COMPACT ALPHA LITHOTRIPTER | Dornier Medtech America, Inc. | Apr 17, 2001 | SESE |
| K010900 | STS-T LITHOTRIPTER, MODEL STS-T | Medstone Intl., Inc. | Apr 5, 2001 | SESE |
| K010340 | MODULITH LITHOTRIPSY, MODEL SLK FOR THE FRAGMENTATION OF URINARY AND UPPER URETERAL CALCULI | Karl Storz Lithotripsy-America, Inc. | Feb 13, 2001 | SESE |
| K003529 | SONOLITH PRAKTIS, ENDOUROLOGY TABLE PRAKTIS | Edap Technomed, Inc. | Feb 12, 2001 | SESE |
| P970062 | GENESTONE 190 LITHOTRIPTER | Bmt, Inc. | Jun 24, 1998 | APRL |
| P970019 | HEALTHTRONICS LITHOTRON LIHTOTRIPSY SYSTEM | Healthtronics Surgical Services, Inc. | Jul 21, 1997 | APRL |
| P950043 | ECONOLITH(TM) LITHOTRIPTER | Medispec, Ltd. | Apr 7, 1997 | APRL |
| P920034 | TRIPTER-X1 NOVA | Medirex, Inc. | Sep 20, 1996 | APRL |
| P920051 | STORZ MODULITH (TM) LITHOTRIPTER | KARL STORZ Endoscopy-America, Inc. | Feb 17, 1995 | APRL |
| P890066 | THERASONIC LITHOTRIPSY TREATMENT SYSTEM | Focus Surgery, Inc. | Dec 20, 1991 | APWD |
| P880042 | EDAP LT.01 SHOCK WAVE LITHOTRIPTER | Edap International Corp. | Dec 12, 1991 | APWD |
| P890013 | RICHARD WOLF PIEZOLITH E.L.P. LITHOTRIPT MODEL2300 | Richard Wolf Medical Instruments Corp. | Sep 9, 1991 | APRL |
| P870011 | HMT SHOCK PLUG/LITHOTRIPTER ELECTRODE | Towers Perrin | Sep 6, 1990 | APRL |
| P880011 | TECHNOMED INTERNATIONAL SONOLITH 2000 | Edap International Corp. | Jun 23, 1989 | APRL |
| P870018 | LITHOSTAR | Siemens Corp. | Sep 30, 1988 | APRL |
| P870015 | MEDSTONE 1050 ECTRACORPOREAL SHOCK WAVE LITHOTRIPT | Medstone Intl., Inc. | Apr 15, 1988 | APRL |
| P840008 | DORNIER LITHOTRIPTER COMPACT TRANSPORTABLE (DLCT) | Dornier Medtech America, Inc. | Dec 19, 1984 | APRL |
Top Applicants
- Direx Systems Corp. — 7 clearances
- KARL STORZ Endoscopy-America, Inc. — 6 clearances
- Dornier Medtech America, Inc. — 6 clearances
- Medispec, Ltd. — 3 clearances
- Lite-Med, Inc. — 3 clearances
