Product Code: LNS FDA class 2 21 CFR 876.5990

Lithotriptor, Extracorporeal Shock-Wave, Urological

Gastroenterology, Urology

Lithotriptor, Extracorporeal Shock-Wave, Urological is a device that generates focused high-energy shock waves directed from outside the body to fragment kidney stones or other urinary tract calculi into smaller pieces that can be passed naturally, used as a non-invasive alternative to surgical stone removal. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket clearance. The product code is LNS, regulated under 21 CFR 876.5990, within the Gastroenterology/Urology medical specialty. No special flags apply to this device.

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FEI Numbers

Registration Numbers

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Basic Information

Product Code: LNS
Device Class: FDA class 2
Regulation Number: 876.5990
Medical Specialty: Gastroenterology, Urology
Review Panel: GU
Submission Type: 1

Device Characteristics

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GMP Exempt

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Implant

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Life Sustain/Support

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Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 56 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K261086	Break Wave	Apr 29, 2026	Substantially Equivalent	Sonomotion, Inc.
K252913	Break Wave	Jan 12, 2026	Substantially Equivalent	Sonomotion, Inc.
K242922	Extracorporeal Shock Wave Lithotripter (U200)	Jun 18, 2025	Substantially Equivalent	Shenzhen Wikkon Precision Technologies Co., Ltd.
K221903	Delta III Pro	Feb 22, 2023	Substantially Equivalent	Dornier Medtech America, Inc.
K213772	LM-9300 Plus Lithotripter	Jan 19, 2023	Substantially Equivalent	Lite-Med, Inc.
K201001	Modulith SLX-F2	Mar 30, 2021	Substantially Equivalent	Karl Storz Endoscopy America
K201074	Delta III Lithotripter	Sep 03, 2020	Substantially Equivalent	Dornier Medtech America, Inc.
K172084	Delta III Lithotripter	Aug 08, 2017	Substantially Equivalent	Dornier Medtech America, Inc.
K170122	Delta III Lithotripter	Jun 28, 2017	Substantially Equivalent	Dornier Medtech America
K151298	Gemini XXP-HP	Jul 30, 2015	Substantially Equivalent	Dornier Medtech America
K142561	LM-9300 ELMA Lithotripter	Mar 20, 2015	Substantially Equivalent	Lite-Med, Inc.
K131817	EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER	Sep 26, 2014	Substantially Equivalent	Osmunda Medical Device Consulting Co., Ltd.
K131721	EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER, COMED ASADAL-M1	Jul 22, 2014	Substantially Equivalent	Comed Medical Systems Co., Ltd.
K132672	EXTRA CORPOREAL SHOCKWAVE LITHOTRIPTER	Sep 23, 2013	Substantially Equivalent	Dornier Medtech America
K130729	EXTRA CORPOREAL SHOCKWAVE LITHOTRIPTER	May 14, 2013	Substantially Equivalent	Dornier Medtech Systems
K121656	GEMINI LITHOTRIPTER	Sep 24, 2012	Substantially Equivalent	Dornier Medtech America, Inc.
K120769	MODULTH SLK	Jun 12, 2012	Substantially Equivalent	KARL STORZ Endoscopy-America, Inc.
K111947	DUET MAGNA	Mar 01, 2012	Substantially Equivalent	Direx Systems Corp.
K103217	LITE-MED LM-9200 ELMA	Sep 28, 2011	Substantially Equivalent	Lite-Med, Inc.
K111808	SONOLITH I-MOVE	Aug 01, 2011	Substantially Equivalent	Edap Tms France
K101482	EM-9000	Mar 31, 2011	Substantially Equivalent	Elite Medical, Inc.
K083614	SONOLITH I-SYS LITHOTRIPER	Jul 27, 2009	Substantially Equivalent	Technomed Medical Systems, SA
K072538	PIEZOLITH 3000 TRIPLE-FOCUS LITHOTRIPTER	Jan 30, 2008	Substantially Equivalent	United Medical Systems, Inc.
K070665	LITHOSKOP	Jan 04, 2008	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K072788	STORZ MODULITH LITHOTRIPTER SLX-F2-F180	Dec 26, 2007	Substantially Equivalent	KARL STORZ Endoscopy-America, Inc.
K070799	MODULARIS VARIOSTAR	Nov 01, 2007	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K070579	STORZ SLX-F2 STORM TOUCH	Aug 30, 2007	Substantially Equivalent	KARL STORZ Endoscopy-America, Inc.
K063504	ECONOLITH EM1000	Mar 09, 2007	Substantially Equivalent	Medispec, Ltd.
K061350	LITHODIAMOND ULTRA	Dec 22, 2006	Substantially Equivalent	Pck Electronic Industry & Trade Co., Ltd.
K062081	LITHOGOLD	Nov 02, 2006	Substantially Equivalent	Tissue Regeneration Technologies, Inc.
K062147	INTEGRA SL	Oct 20, 2006	Substantially Equivalent	Direx Systems Corp.
K053640	INTEGRA	Mar 01, 2006	Substantially Equivalent	Direx Systems Corp.
K050091	TRIPTER-X1 COMPACT DUET SP (SEPARATED PULSE)	Mar 16, 2005	Substantially Equivalent	Direx Systems Corp.
K042427	GENESTONE EXEL (XL) EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER	Dec 03, 2004	Substantially Equivalent	Genemed, Inc.
K042561	TWINHEADS TH-103 EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER	Oct 12, 2004	Substantially Equivalent	Fmd, LLC
K040476	STORZ MODULITH, MODEL SLX-F2	Aug 26, 2004	Substantially Equivalent	KARL STORZ Endoscopy-America, Inc.
K040741	ULTRASOUND LOCALIZATION SYSTEM ULS 0142	Aug 19, 2004	Substantially Equivalent	Hmt High Medical Technologies AG
K041582	MODIFICATION TO TRIPTER X-1 COMPACT DUET	Jul 07, 2004	Substantially Equivalent	Direx Systems Corp.
K040461	ECONOLITH E3000, MODEL 3000 (SW-6)	May 25, 2004	Substantially Equivalent	Medispec, Ltd.
K040470	TRIPTER X-1 COMPACT	Apr 28, 2004	Substantially Equivalent	Direx Systems Corp.
K032958	PIEZOLITH 3000 LITHOTRIPTER, MODEL 3000	Feb 17, 2004	Substantially Equivalent	United Medical Systems, Inc.
K030346	TWINHEADS TH-101 EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER	May 02, 2003	Substantially Equivalent	Fmd, LLC
K023535	TRIPTER X-1 COMPACT DUET	Jan 17, 2003	Substantially Equivalent	Direx Systems Corp.
K021775	LTFS230	Dec 23, 2002	Substantially Equivalent	Healthtronics, Inc.
K011700	MODULITH SLK LITHOTRIPTER	Aug 16, 2002	Substantially Equivalent	Karl Storz Endoscopy
K013471	DELTA 2000 SERIES EXTRACORPOREAL LITHOTRIPTER	Apr 29, 2002	Substantially Equivalent	E.S.W.L. Products, Inc.
K011106	STONELITH, MODEL V5	Feb 11, 2002	Substantially Equivalent	Pck Electronic Industry and Trade Co, Ltd.
K012785	TWINTRODE ELC 134 ELECTRODE	Nov 16, 2001	Substantially Equivalent	Healthtronics Surgical Services, Inc.
K012482	STORZ MODULITH SLK LITHOTRIPTER WITH MULTIVIEW OPTION	Oct 16, 2001	Substantially Equivalent	KARL STORZ Endoscopy-America, Inc.
K011873	DORNIER LITHOTRIPTER S(DOLI S) & DORNIER LITHOTRIPTER S-XP (DOLI S-XP)	Aug 31, 2001	Substantially Equivalent	Dornier
K011773	DORNIER LITHOTRIPTER 140(DOLI 140)	Jun 22, 2001	Substantially Equivalent	Dornier
K002801	MPS M ELECTRODE	May 04, 2001	Unknown	Medical Physics and Services, Inc.
K002929	DORNIER COMPACT ALPHA LITHOTRIPTER	Apr 17, 2001	Substantially Equivalent	Dornier Medtech America, Inc.
K010900	STS-T LITHOTRIPTER, MODEL STS-T	Apr 05, 2001	Substantially Equivalent	Medstone Intl., Inc.
K010340	MODULITH LITHOTRIPSY, MODEL SLK FOR THE FRAGMENTATION OF URINARY AND UPPER URETERAL CALCULI	Feb 13, 2001	Substantially Equivalent	Karl Storz Lithotripsy-America, Inc.
K003529	SONOLITH PRAKTIS, ENDOUROLOGY TABLE PRAKTIS	Feb 12, 2001	Substantially Equivalent	Edap Technomed, Inc.