Panels › Gastroenterology, Urology › Product code LNS · Class 2
Lithotriptor, Extracorporeal Shock-Wave, Urological
Regulation 876.5990
2510(k)s in 12 months (56 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in LNS
| Company | 510(k)s | Recalls |
|---|---|---|
| Dornier Medtech America | 8 | 0 |
| Direx Systems Corp. | 7 | 0 |
| KARL STORZ Endoscopy-America, Inc. | 6 | 0 |
| Lite-Med, Inc. | 3 | 0 |
| Siemens Medical Solutions USA, Inc. | 2 | 1 |
| Dornier | 2 | 0 |
| Fmd, LLC | 2 | 0 |
| Medispec, Ltd. | 2 | 0 |
| Sonomotion, Inc. | 2 | 0 |
| United Medical Systems, Inc. | 2 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 29, 2026 | K261086 | Break Wave Sonomotion, Inc. | LNS |
| Jan 12, 2026 | K252913 | Break Wave Sonomotion, Inc. | LNS |
| Jun 18, 2025 | K242922 | Extracorporeal Shock Wave Lithotripter (U200) Shenzhen Wikkon Precision Technologies Co., Ltd., CN | LNS |
| Feb 22, 2023 | K221903 | Delta III Pro Dornier Medtech America, Inc. | LNS |
| Jan 19, 2023 | K213772 | LM-9300 Plus Lithotripter Lite-Med, Inc., TW | LNS |
| Mar 30, 2021 | K201001 | Modulith SLX-F2 Karl Storz Endoscopy America | LNS |
| Sep 3, 2020 | K201074 | Delta III Lithotripter Dornier Medtech America, Inc. | LNS |
| Aug 8, 2017 | K172084 | Delta III Lithotripter Dornier Medtech America, Inc. | LNS |
| Jun 28, 2017 | K170122 | Delta III Lithotripter Dornier Medtech America | LNS |
| Jul 30, 2015 | K151298 | Gemini XXP-HP Dornier Medtech America | LNS |
| Mar 20, 2015 | K142561 | LM-9300 ELMA Lithotripter Lite-Med, Inc., TW | LNS |
| Sep 26, 2014 | K131817 | EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER Osmunda Medical Device Consulting Co., Ltd., CN | LNS |
| Jul 22, 2014 | K131721 | EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER, COMED ASADAL-M1 Comed Medical Systems Co., Ltd. | LNS |
| Sep 23, 2013 | K132672 | EXTRA CORPOREAL SHOCKWAVE LITHOTRIPTER Dornier Medtech America | LNS |
| May 14, 2013 | K130729 | EXTRA CORPOREAL SHOCKWAVE LITHOTRIPTER Dornier Medtech Systems | LNS |
| Sep 24, 2012 | K121656 | GEMINI LITHOTRIPTER Dornier Medtech America, Inc. | LNS |
| Jun 12, 2012 | K120769 | MODULTH SLK KARL STORZ Endoscopy-America, Inc. | LNS |
| Mar 1, 2012 | K111947 | DUET MAGNA Direx Systems Corp. | LNS |
| Sep 28, 2011 | K103217 | LITE-MED LM-9200 ELMA Lite-Med, Inc., TW | LNS |
| Aug 1, 2011 | K111808 | SONOLITH I-MOVE Edap Tms France | LNS |
| Mar 31, 2011 | K101482 | EM-9000 Elite Medical, Inc. | LNS |
| Jul 27, 2009 | K083614 | SONOLITH I-SYS LITHOTRIPER Technomed Medical Systems, SA | LNS |
| Jan 30, 2008 | K072538 | PIEZOLITH 3000 TRIPLE-FOCUS LITHOTRIPTER United Medical Systems, Inc. | LNS |
| Jan 4, 2008 | K070665 | LITHOSKOP Siemens Medical Solutions USA, Inc. | LNS |
| Dec 26, 2007 | K072788 | STORZ MODULITH LITHOTRIPTER SLX-F2-F180 KARL STORZ Endoscopy-America, Inc. | LNS |
| Nov 1, 2007 | K070799 | MODULARIS VARIOSTAR Siemens Medical Solutions USA, Inc. | LNS |
| Aug 30, 2007 | K070579 | STORZ SLX-F2 STORM TOUCH KARL STORZ Endoscopy-America, Inc. | LNS |
| Mar 9, 2007 | K063504 | ECONOLITH EM1000 Medispec, Ltd. | LNS |
| Dec 22, 2006 | K061350 | LITHODIAMOND ULTRA Pck Electronic Industry & Trade Co., Ltd. | LNS |
| Nov 2, 2006 | K062081 | LITHOGOLD Tissue Regeneration Technologies, Inc. | LNS |
| Oct 20, 2006 | K062147 | INTEGRA SL Direx Systems Corp. | LNS |
| Mar 1, 2006 | K053640 | INTEGRA Direx Systems Corp. | LNS |
| Mar 16, 2005 | K050091 | TRIPTER-X1 COMPACT DUET SP (SEPARATED PULSE) Direx Systems Corp. | LNS |
| Dec 3, 2004 | K042427 | GENESTONE EXEL (XL) EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER Genemed, Inc. | LNS |
| Oct 12, 2004 | K042561 | TWINHEADS TH-103 EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER Fmd, LLC | LNS |
| Aug 26, 2004 | K040476 | STORZ MODULITH, MODEL SLX-F2 KARL STORZ Endoscopy-America, Inc. | LNS |
| Aug 19, 2004 | K040741 | ULTRASOUND LOCALIZATION SYSTEM ULS 0142 Hmt High Medical Technologies AG | LNS |
| Jul 7, 2004 | K041582 | MODIFICATION TO TRIPTER X-1 COMPACT DUET Direx Systems Corp. | LNS |
| May 25, 2004 | K040461 | ECONOLITH E3000, MODEL 3000 (SW-6) Medispec, Ltd. | LNS |
| Apr 28, 2004 | K040470 | TRIPTER X-1 COMPACT Direx Systems Corp. | LNS |
| Feb 17, 2004 | K032958 | PIEZOLITH 3000 LITHOTRIPTER, MODEL 3000 United Medical Systems, Inc. | LNS |
| May 2, 2003 | K030346 | TWINHEADS TH-101 EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER Fmd, LLC | LNS |
| Jan 17, 2003 | K023535 | TRIPTER X-1 COMPACT DUET Direx Systems Corp. | LNS |
| Dec 23, 2002 | K021775 | LTFS230 Healthtronics, Inc. | LNS |
| Aug 16, 2002 | K011700 | MODULITH SLK LITHOTRIPTER Karl Storz Endoscopy | LNS |
| Apr 29, 2002 | K013471 | DELTA 2000 SERIES EXTRACORPOREAL LITHOTRIPTER E.S.W.L. Products, Inc. | LNS |
| Feb 11, 2002 | K011106 | STONELITH, MODEL V5 Pck Electronic Industry and Trade Co, Ltd., TR | LNS |
| Nov 16, 2001 | K012785 | TWINTRODE ELC 134 ELECTRODE Healthtronics Surgical Services, Inc. | LNS |
| Oct 16, 2001 | K012482 | STORZ MODULITH SLK LITHOTRIPTER WITH MULTIVIEW OPTION KARL STORZ Endoscopy-America, Inc. | LNS |
| Aug 31, 2001 | K011873 | DORNIER LITHOTRIPTER S(DOLI S) & DORNIER LITHOTRIPTER S-XP (DOLI S-XP) Dornier | LNS |
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