Product code LNS
- Device name
- Lithotriptor, Extracorporeal Shock-Wave, Urological
- Medical specialty
- Gastroenterology, Urology
- Device class
- 2
- Regulation number
- 876.5990
- Review panel
- GU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related PMA Records#
| PMA | Device | Applicant | Decision date |
|---|---|---|---|
| P870015S036 | TRANSPORTABLE MODEL STS-T LITHOTRIPTER | Medstone Intl., Inc. | 2000-07-26 |
| P870018S025 | LITHOSTAR MODULARIS | Siemens Corp. | 2000-07-17 |
| P870018S024 | LITHOSTAR MODULARIS | Siemens Corp. | 2000-04-17 |
| P870015S035 | TRANSPORTABLE MODEL STS-T LITHOTRIPTER | Medstone Intl., Inc. | 2000-02-25 |
| P970019S006 | LITHOTRON ULS | Healthtronics Surgical Services, Inc. | 1999-12-17 |
| P870015S034 | TRANSPORTABLE MODEL STS-T LITHOTRIPTER | Medstone Intl., Inc. | 1999-11-19 |
| P840008S069 | DORNIER COMPACT DELTA LITHOTRIPTER-STATIONARY, MOBILE AND TRANSPORTABLE/FS2000 X-RAY MODULE | Dornier Medtech America, Inc. | 1999-09-02 |
| P950043S006 | ECONOLITH LITHOTRIPTER | Medispec, Ltd. | 1999-08-27 |
| P870015S033 | MEDSTONE STS-T LITHOTRIPTER | Medstone Intl., Inc. | 1999-06-21 |
| P870018S023 | LITHOSTAR MULTILINE | Siemens Corp. | 1999-04-30 |
| P840008S067 | DORNIER LITHOTRIPTER-DOLI S AND COMPACT DELTA | Dornier Medtech America, Inc. | 1999-03-12 |
| P870015S031 | MEDSTONE STS-T LITHOTRIPTER | Medstone Intl., Inc. | 1999-03-11 |
| P840008S068 | DORNIER COMPACT DELTA LITHOTRIPTER-STATIONARY, MOBILE/TRANSPORTABLE | Dornier Medtech America, Inc. | 1999-02-26 |
| P870018S022 | TRANSMOBILE LITHOSTAR MODULARIS | Siemens Corp. | 1999-01-21 |
| P920034S003 | TRIPTER-X1 | Medirex, Inc. | 1998-12-14 |
| P970019S003 | HEALTHTRONICS LITHOTRON LIHTOTRIPSY SYSTEM | Healthtronics Surgical Services, Inc. | 1998-11-18 |
| P970019S005 | LITHO TRON LITHOTRIPSY SYSTEM | Healthtronics Surgical Services, Inc. | 1998-11-17 |
| P870018S021 | MODULARIS LITHO | Siemens Corp. | 1998-09-21 |
| P870015S030 | MEDSTONE STS-T TRANSPORTABLE LITHOTRIPTER | Medstone Intl., Inc. | 1998-09-16 |
| P950043S005 | ECONOLITH(TM) LITHOTRIPTER | Medispec, Ltd. | 1998-09-14 |
| P970019S004 | LITHOTRON ULTRA LITHOSTRIPSY SYSTEM | Healthtronics Surgical Services, Inc. | 1998-09-11 |
| P870018S017 | LITHOSTAR MULTILINE | Siemens Corp. | 1998-08-26 |
| P840008S066 | DORNIER COMPACT DELTA LITHOTRIPTER | Dornier Medtech America, Inc. | 1998-08-21 |
| P970019S002 | HEALTHTRONICS LITHOTRON LIHTOTRIPSY SYSTEM | Healthtronics Surgical Services, Inc. | 1998-07-14 |
| P840008S065 | DORNIER COMPACT DELTA | Dornier Medtech America, Inc. | 1998-07-07 |
| P970062 | GENESTONE 190 LITHOTRIPTER | Bmt, Inc. | 1998-06-24 |
| P840008S063 | DORNIER LITHOTRIPTER (STATIONARY AND MOBILE) | Dornier Medtech America, Inc. | 1998-06-19 |
| P840008S064 | DORNIER LITHOTRIPTER (STATIONARY AND MOBILE) | Dornier Medtech America, Inc. | 1998-06-05 |
| P950043S004 | ECONOLITH(TM) LITHOTRIPTER | Medispec, Ltd. | 1998-05-21 |
| P840008S062 | DORNIER LITHOTRIPTER AND DORNIER COMPACT S LITHOTRIPTER | Dornier Medtech America, Inc. | 1998-05-14 |
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261086 | Break Wave | Sonomotion, Inc. | 2026-04-29 |
| K252913 | Break Wave | Sonomotion, Inc. | 2026-01-12 |
| K242922 | Extracorporeal Shock Wave Lithotripter (U200) | Shenzhen Wikkon Precision Technologies Co., Ltd. | 2025-06-18 |
| K221903 | Delta III Pro | Dornier Medtech America, Inc. | 2023-02-22 |
| K213772 | LM-9300 Plus Lithotripter | Lite-Med, Inc. | 2023-01-19 |
| K201001 | Modulith SLX-F2 | Karl Storz Endoscopy America | 2021-03-30 |
| K201074 | Delta III Lithotripter | Dornier Medtech America, Inc. | 2020-09-03 |
| K172084 | Delta III Lithotripter | Dornier Medtech America, Inc. | 2017-08-08 |
| K170122 | Delta III Lithotripter | Dornier Medtech America | 2017-06-28 |
| K151298 | Gemini XXP-HP | Dornier Medtech America | 2015-07-30 |
| K142561 | LM-9300 ELMA Lithotripter | Lite-Med, Inc. | 2015-03-20 |
| K131817 | EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER | Osmunda Medical Device Consulting Co., Ltd. | 2014-09-26 |
| K131721 | EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER, COMED ASADAL-M1 | Comed Medical Systems Co., Ltd. | 2014-07-22 |
| K132672 | EXTRA CORPOREAL SHOCKWAVE LITHOTRIPTER | Dornier Medtech America | 2013-09-23 |
| K130729 | EXTRA CORPOREAL SHOCKWAVE LITHOTRIPTER | Dornier Medtech Systems | 2013-05-14 |
| K121656 | GEMINI LITHOTRIPTER | Dornier Medtech America, Inc. | 2012-09-24 |
| K120769 | MODULTH SLK | KARL STORZ Endoscopy-America, Inc. | 2012-06-12 |
| K111947 | DUET MAGNA | Direx Systems Corp. | 2012-03-01 |
| K103217 | LITE-MED LM-9200 ELMA | Lite-Med, Inc. | 2011-09-28 |
| K111808 | SONOLITH I-MOVE | Edap Tms France | 2011-08-01 |
| K101482 | EM-9000 | Elite Medical, Inc. | 2011-03-31 |
| K083614 | SONOLITH I-SYS LITHOTRIPER | Technomed Medical Systems, SA | 2009-07-27 |
| K072538 | PIEZOLITH 3000 TRIPLE-FOCUS LITHOTRIPTER | United Medical Systems, Inc. | 2008-01-30 |
| K070665 | LITHOSKOP | Siemens Medical Solutions USA, Inc. | 2008-01-04 |
| K072788 | STORZ MODULITH LITHOTRIPTER SLX-F2-F180 | KARL STORZ Endoscopy-America, Inc. | 2007-12-26 |
| K070799 | MODULARIS VARIOSTAR | Siemens Medical Solutions USA, Inc. | 2007-11-01 |
| K070579 | STORZ SLX-F2 STORM TOUCH | KARL STORZ Endoscopy-America, Inc. | 2007-08-30 |
| K063504 | ECONOLITH EM1000 | Medispec, Ltd. | 2007-03-09 |
| K061350 | LITHODIAMOND ULTRA | Pck Electronic Industry & Trade Co., Ltd. | 2006-12-22 |
| K062081 | LITHOGOLD | Tissue Regeneration Technologies, Inc. | 2006-11-02 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00810000980628 | PIEZOLITH 3000 TRIPLE-FOCUS LITHOTRIPSY SYSTEM COMPLETE | UNITED SERVICE SOLUTIONS, LLC | 2020-01-29 |
| 00810000980765 | PIEZOLITH 3000 TRIPLE-FOCUS LITHOTRIPSY SYSTEM COMPLETE | UNITED SERVICE SOLUTIONS, LLC | 2020-01-29 |
| 00810000980758 | PIEZOLITH 3000 TRIPLE-FOCUS LITHOTRIPSY SYSTEM COMPLETE | UNITED SERVICE SOLUTIONS, LLC | 2020-01-29 |
| 00810000980741 | PIEZOLITH 3000 TRIPLE-FOCUS LITHOTRIPSY SYSTEM COMPLETE | UNITED SERVICE SOLUTIONS, LLC | 2020-01-29 |
| 00810000980734 | PIEZOLITH 3000 TRIPLE-FOCUS LITHOTRIPSY SYSTEM COMPLETE | UNITED SERVICE SOLUTIONS, LLC | 2020-01-29 |
| 00810000980727 | PIEZOLITH 3000 TRIPLE-FOCUS LITHOTRIPSY SYSTEM COMPLETE | UNITED SERVICE SOLUTIONS, LLC | 2020-01-29 |
| 00810000980710 | PIEZOLITH 3000 TRIPLE-FOCUS LITHOTRIPSY SYSTEM COMPLETE | UNITED SERVICE SOLUTIONS, LLC | 2020-01-29 |
| 00810000980703 | PIEZOLITH 3000 TRIPLE-FOCUS LITHOTRIPSY SYSTEM COMPLETE | UNITED SERVICE SOLUTIONS, LLC | 2020-01-29 |
| 00810000980697 | PIEZOLITH 3000 TRIPLE-FOCUS LITHOTRIPSY SYSTEM COMPLETE | UNITED SERVICE SOLUTIONS, LLC | 2020-01-29 |
| 00810000980680 | PIEZOLITH 3000 TRIPLE-FOCUS LITHOTRIPSY SYSTEM COMPLETE | UNITED SERVICE SOLUTIONS, LLC | 2020-01-29 |
| 00810000980673 | PIEZOLITH 3000 TRIPLE-FOCUS LITHOTRIPSY SYSTEM COMPLETE | UNITED SERVICE SOLUTIONS, LLC | 2020-01-29 |
| 00810000980666 | PIEZOLITH 3000 TRIPLE-FOCUS LITHOTRIPSY SYSTEM COMPLETE | UNITED SERVICE SOLUTIONS, LLC | 2020-01-29 |
| 00810000980659 | PIEZOLITH 3000 TRIPLE-FOCUS LITHOTRIPSY SYSTEM COMPLETE | UNITED SERVICE SOLUTIONS, LLC | 2020-01-29 |
| 00810000980642 | PIEZOLITH 3000 TRIPLE-FOCUS LITHOTRIPSY SYSTEM COMPLETE | UNITED SERVICE SOLUTIONS, LLC | 2020-01-29 |
| 00810000980635 | PIEZOLITH 3000 TRIPLE-FOCUS LITHOTRIPSY SYSTEM COMPLETE | UNITED SERVICE SOLUTIONS, LLC | 2020-01-29 |
| 00810000980475 | PIEZOLITH 3000 TRIPLE-FOCUS LITHOTRIPSY SYSTEM COMPLETE | UNITED SERVICE SOLUTIONS, LLC | 2020-01-29 |
| 00810000980611 | PIEZOLITH 3000 TRIPLE-FOCUS LITHOTRIPSY SYSTEM COMPLETE | UNITED SERVICE SOLUTIONS, LLC | 2020-01-29 |
| 00810000980604 | PIEZOLITH 3000 TRIPLE-FOCUS LITHOTRIPSY SYSTEM COMPLETE | UNITED SERVICE SOLUTIONS, LLC | 2020-01-29 |
| 00810000980598 | PIEZOLITH 3000 TRIPLE-FOCUS LITHOTRIPSY SYSTEM COMPLETE | UNITED SERVICE SOLUTIONS, LLC | 2020-01-29 |
| 00810000980581 | PIEZOLITH 3000 TRIPLE-FOCUS LITHOTRIPSY SYSTEM COMPLETE | UNITED SERVICE SOLUTIONS, LLC | 2020-01-29 |
| 00810000980574 | PIEZOLITH 3000 TRIPLE-FOCUS LITHOTRIPSY SYSTEM COMPLETE | UNITED SERVICE SOLUTIONS, LLC | 2020-01-29 |
| 00810000980567 | PIEZOLITH 3000 TRIPLE-FOCUS LITHOTRIPSY SYSTEM COMPLETE | UNITED SERVICE SOLUTIONS, LLC | 2020-01-29 |
| 00810000980550 | PIEZOLITH 3000 TRIPLE-FOCUS LITHOTRIPSY SYSTEM COMPLETE | UNITED SERVICE SOLUTIONS, LLC | 2020-01-29 |
| 00810000980543 | PIEZOLITH 3000 TRIPLE-FOCUS LITHOTRIPSY SYSTEM COMPLETE | UNITED SERVICE SOLUTIONS, LLC | 2020-01-29 |
| 00810000980536 | PIEZOLITH 3000 TRIPLE-FOCUS LITHOTRIPSY SYSTEM COMPLETE | UNITED SERVICE SOLUTIONS, LLC | 2020-01-29 |
| 00810000980529 | PIEZOLITH 3000 TRIPLE-FOCUS LITHOTRIPSY SYSTEM COMPLETE | UNITED SERVICE SOLUTIONS, LLC | 2020-01-29 |
| 00810000980512 | PIEZOLITH 3000 TRIPLE-FOCUS LITHOTRIPSY SYSTEM COMPLETE | UNITED SERVICE SOLUTIONS, LLC | 2020-01-29 |
| 00810000980505 | PIEZOLITH 3000 TRIPLE-FOCUS LITHOTRIPSY SYSTEM COMPLETE | UNITED SERVICE SOLUTIONS, LLC | 2020-01-29 |
| 00810000980499 | PIEZOLITH 3000 TRIPLE-FOCUS LITHOTRIPSY SYSTEM COMPLETE | UNITED SERVICE SOLUTIONS, LLC | 2020-01-29 |
| 00810000980482 | PIEZOLITH 3000 TRIPLE-FOCUS LITHOTRIPSY SYSTEM COMPLETE | UNITED SERVICE SOLUTIONS, LLC | 2020-01-29 |