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
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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