FDA 510(k) Applications for Medical Device Product Code "LNS"
(Lithotriptor, Extracorporeal Shock-Wave,Urological)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K131721 | COMED MEDICAL SYSTEMS CO., LTD | EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER, COMED ASADAL-M1 | 07/22/2014 |
| K111947 | DIREX SYSTEMS CORP. | DUET MAGNA | 03/01/2012 |
| K053640 | DIREX SYSTEMS CORP. | INTEGRA | 03/01/2006 |
| K062147 | DIREX SYSTEMS CORP. | INTEGRA SL | 10/20/2006 |
| K041582 | DIREX SYSTEMS CORP. | MODIFICATION TO TRIPTER X-1 COMPACT DUET | 07/07/2004 |
| K040470 | DIREX SYSTEMS CORP. | TRIPTER X-1 COMPACT | 04/28/2004 |
| K023535 | DIREX SYSTEMS CORP. | TRIPTER X-1 COMPACT DUET | 01/17/2003 |
| K050091 | DIREX SYSTEMS CORP. | TRIPTER-X1 COMPACT DUET SP (SEPARATED PULSE) | 03/16/2005 |
| K011773 | DORNIER | DORNIER LITHOTRIPTER 140(DOLI 140) | 06/22/2001 |
| K011873 | DORNIER | DORNIER LITHOTRIPTER S(DOLI S) & DORNIER LITHOTRIPTER S-XP (DOLI S-XP) | 08/31/2001 |
| K170122 | Dornier MedTech America | Delta III Lithotripter | 06/28/2017 |
| K132672 | DORNIER MEDTECH AMERICA | EXTRA CORPOREAL SHOCKWAVE LITHOTRIPTER | 09/23/2013 |
| K151298 | Dornier MedTech America | Gemini XXP-HP | 07/30/2015 |
| K221903 | Dornier MedTech America, Inc | Delta III Pro | 02/22/2023 |
| K172084 | Dornier MedTech America, Inc. | Delta III Lithotripter | 08/08/2017 |
| K201074 | Dornier MedTech America, Inc. | Delta III Lithotripter | 09/03/2020 |
| K002929 | DORNIER MEDTECH AMERICA, INC. | DORNIER COMPACT ALPHA LITHOTRIPTER | 04/17/2001 |
| K121656 | DORNIER MEDTECH AMERICA, INC. | GEMINI LITHOTRIPTER | 09/24/2012 |
| K130729 | DORNIER MEDTECH SYSTEMS | EXTRA CORPOREAL SHOCKWAVE LITHOTRIPTER | 05/14/2013 |
| K013471 | E.S.W.L. PRODUCTS, INC. | DELTA 2000 SERIES EXTRACORPOREAL LITHOTRIPTER | 04/29/2002 |
| K003529 | EDAP TECHNOMED, INC. | SONOLITH PRAKTIS, ENDOUROLOGY TABLE PRAKTIS | 02/12/2001 |
| K111808 | EDAP TMS FRANCE | SONOLITH I-MOVE | 08/01/2011 |
| K101482 | ELITE MEDICAL INC | EM-9000 | 03/31/2011 |
| K030346 | FMD, LLC | TWINHEADS TH-101 EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER | 05/02/2003 |
| K042561 | FMD, LLC | TWINHEADS TH-103 EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER | 10/12/2004 |
| K042427 | GENEMED, INC. | GENESTONE EXEL (XL) EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER | 12/03/2004 |
| K012785 | HEALTH TRONICS SURGICAL SERVICES, INC. | TWINTRODE ELC 134 ELECTRODE | 11/16/2001 |
| K021775 | HEALTHTRONICS, INC. | LTFS230 | 12/23/2002 |
| K040741 | HMT HIGH MEDICAL TECHNOLOGIES AG | ULTRASOUND LOCALIZATION SYSTEM ULS 0142 | 08/19/2004 |
| K011700 | KARL STORZ ENDOSCOPY | MODULITH SLK LITHOTRIPTER | 08/16/2002 |
| K201001 | KARL STORZ Endoscopy America | Modulith SLX-F2 | 03/30/2021 |
| K120769 | KARL STORZ ENDOSCOPY-AMERICA, INC. | MODULTH SLK | 06/12/2012 |
| K072788 | KARL STORZ ENDOSCOPY-AMERICA, INC. | STORZ MODULITH LITHOTRIPTER SLX-F2-F180 | 12/26/2007 |
| K012482 | KARL STORZ ENDOSCOPY-AMERICA, INC. | STORZ MODULITH SLK LITHOTRIPTER WITH MULTIVIEW OPTION | 10/16/2001 |
| K040476 | KARL STORZ ENDOSCOPY-AMERICA, INC. | STORZ MODULITH, MODEL SLX-F2 | 08/26/2004 |
| K070579 | KARL STORZ ENDOSCOPY-AMERICA, INC. | STORZ SLX-F2 STORM TOUCH | 08/30/2007 |
| K010340 | KARL STORZ LITHOTRIPSY-AMERICA, INC. | MODULITH LITHOTRIPSY, MODEL SLK FOR THE FRAGMENTATION OF URINARY AND UPPER URETERAL CALCULI | 02/13/2001 |
| K103217 | LITE-MED INC | LITE-MED LM-9200 ELMA | 09/28/2011 |
| K142561 | LITE-MED INC. | LM-9300 ELMA Lithotripter | 03/20/2015 |
| K213772 | Lite-Med Inc. | LM-9300 Plus Lithotripter | 01/19/2023 |
| K002801 | MEDICAL PHYSICS AND SERVICES, INC. | MPS M ELECTRODE | 05/04/2001 |
| K040461 | MEDISPEC, LTD. | ECONOLITH E3000, MODEL 3000 (SW-6) | 05/25/2004 |
| K063504 | MEDISPEC, LTD. | ECONOLITH EM1000 | 03/09/2007 |
| K010900 | MEDSTONE INTL., INC. | STS-T LITHOTRIPTER, MODEL STS-T | 04/05/2001 |
| K131817 | OSMUNDA MEDICAL DEVICE CONSULTING CO., LTD. | EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER | 09/26/2014 |
| K061350 | PCK ELECTRONIC INDUSTRY & TRADE CO., LTD. | LITHODIAMOND ULTRA | 12/22/2006 |
| K011106 | PCK ELECTRONIC INDUSTRY AND TRADE CO, LTD | STONELITH, MODEL V5 | 02/11/2002 |
| K242922 | Shenzhen Wikkon Precision Technologies Co., Ltd. | Extracorporeal Shock Wave Lithotripter (U200) | 06/18/2025 |
| K070799 | SIEMENS MEDICAL SOLUTIONS USA INC. | MODULARIS VARIOSTAR | 11/01/2007 |
| K070665 | SIEMENS MEDICAL SOLUTIONS USA, INC. | LITHOSKOP | 01/04/2008 |
| K083614 | TECHNOMED MEDICAL SYSTEMS, SA | SONOLITH I-SYS LITHOTRIPER | 07/27/2009 |
| K062081 | TISSUE REGENERATION TECHNOLOGIES, INC. | LITHOGOLD | 11/02/2006 |
| K032958 | UNITED MEDICAL SYSTEMS, INC. | PIEZOLITH 3000 LITHOTRIPTER, MODEL 3000 | 02/17/2004 |
| K072538 | UNITED MEDICAL SYSTEMS, INC. | PIEZOLITH 3000 TRIPLE-FOCUS LITHOTRIPTER | 01/30/2008 |
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