Piezolith
LITHOTRIPTER 3000 for stone fragmentation of renal hollow system (renal pelvis and calyces) and in the upper, middle and lower ureter, for extracorporal shock wave lithotripsy, with…
LITHOTRIPTER 3000 for stone fragmentation of renal hollow system (renal pelvis and calyces) and in the upper, middle and lower ureter, for extracorporal shock wave lithotripsy, with articulated arm, total energy (12mm) 123mJ, peak pressure (p+) 8 – 126MPa, penetration max. 165mm, focal length F1/F2/F3 (X/YxZ): F1 3,7×30/F2 4,8×32/F3 8,7x63mm, U: 110-120VAC, 50/60Hz, Dim wxhxd 1000x700x1200mm
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 | Richard Wolf Gmbh, Germany |
|---|---|
| FDA product code | LNS |
| Device type | Lithotriptor, Extracorporeal Shock-Wave, Urological |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5990 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| Record published | 2017-07-21 |
| Record revised | 2025-12-12 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
| Storage | Storage environment temperature 5 to 40 °C; Storage environment humidity 10 to 90 % RH |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 3000002 | In distribution | |
| 3000012 | 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 |
| 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 |
| Modularis Variostar | Siemens Healthcare Limited | 1 |
Showing 12 of 20. All products under Lithotriptor, Extracorporeal Shock-Wave, Urological
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.