Extracorporeal Shock Wave Lithotripter
The U200 Extracorporeal Shock Wave Lithotripter fragments urinary stones in the kidney and ureter without placing the shock wave source inside the body. Ultrasound helps locate the stone…
The U200 Extracorporeal Shock Wave Lithotripter fragments urinary stones in the kidney and ureter without placing the shock wave source inside the body. Ultrasound helps locate the stone and align it with the shock wave focus. The system includes a treatment table, shock wave source, control console and supporting power and computer equipment.
An electromagnetic generator produces pressure pulses in water. An acoustic lens focuses these shock waves onto the stone, where repeated mechanical stresses break it into smaller fragments. A water-filled cushion couples the source to the patient’s body to transmit the pulses.
Listed Item
U200 ESWL system focuses shock waves into the body using ultrasound guidance to fragment urinary calculi (i.e kidney and ureteral stones). U200 system incorporates a shock wave generator, high voltage generator, control console, ultrasound system and patient table. Prior to treatment, the stone is targeted using a stand-alone ultra-sound system. Shock waves are typically generated using electromagnetically repelled membranes. These shock waves are focused onto the stone with specially designed acoustic lens. The shock waves are created under water by the shock wave generator, and are transferred to the patient’s body through a water-filled silicon cushion. Once the stone is fragmented by the focused shock waves, the fragments pass out of the body with the patient’s urine. U200 system is available in stationary configuration, and are indicated for use in a single health care facility
Positioning
The treatment table moves in three dimensions to position the stone at the focus. The computer supports movement control, target calibration and image handling during setup and treatment.
Who Else Makes It
Registered in Guangdong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shenzhen Wikkon Precision Technologies Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 1 |
Record
| Listed by | Shenzhen Wikkon Precision Technologies Co., Ltd., China |
|---|---|
| FDA product code | LNS |
| Device type | Lithotriptor, Extracorporeal Shock-Wave, Urological |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5990 |
| Establishment | Manufacturer |
| 510(k) | K242922 |
| Record published | 2025-07-30 |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Label carries | expiry date, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| U200 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Piezolith 3000 Triple-Focus Lithotripsy System Complete | United Medical Systems (DE), Inc. | 47 |
| Piezolith 3000 Triple-Focus Lithotripsy System Complete | United Service Solutions, LLC | 46 |
| Modulith® | Storz Medical AG | 8 |
| Dornier MedTech | Dornier Medtech Gmbh | 6 |
| Econolith EM1000 | Medispec, Ltd. | 5 |
| Econolith E3000 | Medispec, Ltd. | 2 |
| Dornier Delta III | Dornier Medtech Gmbh | 2 |
| Piezolith | Richard Wolf Gmbh | 2 |
| Sonolith i-move Standard Module | Edap TMS France SA | 1 |
| Compact Duet | Direx Systems Corp. | 1 |
| ASADAL-M1 | Huons Co., Ltd. | 1 |
| Econolith E2000 | Medispec, Ltd. | 1 |
Showing 12 of 20. All products under Lithotriptor, Extracorporeal Shock-Wave, Urological
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K242922 | 2025-06-18 |
PMA Approvals
A premarket approval is the full Class III route, granted on clinical evidence rather than on equivalence to an existing device. It is the highest regulatory bar a device of this type can clear.
| PMA number | Decision | Trade name | Approved to |
|---|---|---|---|
| P870018 | 1999-04-30 | LITHOSTAR MULTILINE | Siemens Healthcare Limited |
| P970019 | 1998-07-14 | HEALTHTRONICS LITHOTRON LIHTOTRIPSY SYSTEM | Healthtronics Surgical Services, Inc. |
| P970062 | 1998-06-24 | GENESTONE 190 LITHOTRIPTER | Bmt, Inc. |
| P950043 | 1998-05-21 | ECONOLITH(TM) LITHOTRIPTER | Medispec, Ltd. |
| P870015 | 1998-03-05 | MEDSTONE STS(TM) LITHOTRIPTER | Medstone Intl., Inc. |
| P920034 | 1997-03-26 | TRIPTER-X1 SERIES SHOCKWAVE LITHOTRIPTERS | Medirex, Inc. |
| P920051 | 1996-06-21 | STORZ MODULITH LITHOTRIPTER, MODEL SLX | Karl Storz Endoscopy-America, Inc. |
| P840008 | 1995-10-05 | DORNIER LITHOTRIPTER TRANSPORTABLE (DLT) | Dornier Medtech America, Inc. |
| P890066 | 1994-04-18 | THERASONIC LITHOTRIPSY TREATMENT SYSTEM | Focus Surgery, Inc. |
| P880042 | 1994-04-18 | EDAP LT.01 SHOCK WAVE LITHOTRIPTER | Edap International Corp. |
| P880011 | 1992-02-10 | TECHNOMED INTERNATIONAL SONOLITH 3000 (LITHORAY)TM | Edap International Corp. |
| P890013 | 1991-09-09 | RICHARD WOLF PIEZOLITH E.L.P. LITHOTRIPT MODEL2300 | Richard Wolf Medical Instruments Corp. |
| P870011 | 1990-09-06 | HMT SHOCK PLUG/LITHOTRIPTER ELECTRODE | Towers Perrin |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.