LNS · Lithotriptor, Extracorporeal Shock-Wave, Urological
Gastroenterology, Urology · 21 CFR 876.5990 · Class 2
Overview
| Product Code | LNS |
|---|---|
| Device Name | Lithotriptor, Extracorporeal Shock-Wave, Urological |
| Regulation | 21 CFR 876.5990 |
| Device Class | Class 2 |
| Review Panel | Gastroenterology, Urology |
Identification
An extracorporeal shock wave lithotripter is a device that focuses ultrasonic shock waves into the body to noninvasively fragment urinary calculi within the kidney or ureter. The primary components of the device are a shock wave generator, high voltage generator, control console, imaging/localization system, and patient table. Prior to treatment, the urinary stone is targeted using either an integral or stand-alone localization/imaging system. Shock waves are typically generated using electrostatic spark discharge (spark gap), electromagnetically repelled membranes, or piezoelectric crystal arrays, and focused onto the stone with either a specially designed reflector, dish, or acoustic lens. The shock waves are created under water within the shock wave generator, and are transferred to the patient's body using an appropriate acoustic interface. After the stone has been fragmented by the focused shock waves, the fragments pass out of the body with the patient's urine.
Classification Rationale
Class II (special controls) (FDA guidance document: “Guidance for the Content of Premarket Notifications (510(k)'s) for Extracorporeal Shock Wave Lithotripters Indicated for the Fragmentation of Kidney and Ureteral Calculi.”)
Special Controls
*Classification.* Class II (special controls) (FDA guidance document: “Guidance for the Content of Premarket Notifications (510(k)'s) for Extracorporeal Shock Wave Lithotripters Indicated for the Fragmentation of Kidney and Ureteral Calculi.”)
Recent Cleared Devices (20 of 68)
Showing 20 most recent of 68 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K252913 | Break Wave | Sonomotion, Inc. | Jan 12, 2026 | SESE |
| K242922 | Extracorporeal Shock Wave Lithotripter (U200) | Shenzhen Wikkon Precision Technologies Co., Ltd. | Jun 18, 2025 | SESE |
| K221903 | Delta III Pro | Dornier Medtech America, Inc. | Feb 22, 2023 | SESE |
| K213772 | LM-9300 Plus Lithotripter | Lite-Med, Inc. | Jan 19, 2023 | SESE |
| K201001 | Modulith SLX-F2 | Karl Storz Endoscopy America | Mar 30, 2021 | SESE |
| K201074 | Delta III Lithotripter | Dornier Medtech America, Inc. | Sep 3, 2020 | SESE |
| K172084 | Delta III Lithotripter | Dornier Medtech America, Inc. | Aug 8, 2017 | SESE |
| K170122 | Delta III Lithotripter | Dornier Medtech America | Jun 28, 2017 | SESE |
| K151298 | Gemini XXP-HP | Dornier Medtech America | Jul 30, 2015 | SESE |
| K142561 | LM-9300 ELMA Lithotripter | Lite-Med, Inc. | Mar 20, 2015 | SESE |
| K131817 | EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER | Osmunda Medical Device Consulting Co., Ltd. | Sep 26, 2014 | SESE |
| K131721 | EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER, COMED ASADAL-M1 | Comed Medical Systems Co., Ltd. | Jul 22, 2014 | SESE |
| K132672 | EXTRA CORPOREAL SHOCKWAVE LITHOTRIPTER | Dornier Medtech America | Sep 23, 2013 | SESE |
| K130729 | EXTRA CORPOREAL SHOCKWAVE LITHOTRIPTER | Dornier Medtech Systems | May 14, 2013 | SESE |
| K121656 | GEMINI LITHOTRIPTER | Dornier Medtech America, Inc. | Sep 24, 2012 | SESE |
| K120769 | MODULTH SLK | KARL STORZ Endoscopy-America, Inc. | Jun 12, 2012 | SESE |
| K111947 | DUET MAGNA | Direx Systems Corp. | Mar 1, 2012 | SESE |
| K103217 | LITE-MED LM-9200 ELMA | Lite-Med, Inc. | Sep 28, 2011 | SESE |
| K111808 | SONOLITH I-MOVE | Edap Tms France | Aug 1, 2011 | SESE |
| K101482 | EM-9000 | Elite Medical, Inc. | Mar 31, 2011 | SESE |
Top Applicants
- Direx Systems Corp. — 7 clearances
- Dornier Medtech America, Inc. — 6 clearances
- KARL STORZ Endoscopy-America, Inc. — 6 clearances
- Dornier Medtech America — 3 clearances
- Lite-Med, Inc. — 3 clearances
