Modulith®
Equipment for the extracorporeal induced shock wave therapy for stationary and mobile use.
1manufacturer
8catalogue numbers in this listing
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 | Storz Medical AG, Switzerland |
|---|---|
| FDA product code | LNS |
| Device type | Lithotriptor, Extracorporeal Shock-Wave, Urological |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5990 |
| Establishment | Manufacturer |
| 510(k) | K070579 |
| Record published | 2021-04-13 |
| Record revised | 2023-02-06 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Distribution end date | 2025-12-31 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SLX-F2 | In distribution | |
| SLX-F2 | In distribution | |
| SLK (1L) | In distribution | |
| SLX-F2 | In distribution | |
| SLX-F2 | In distribution | |
| SLK | In distribution | |
| SLK (0L) | In distribution | |
| SLX-F2 | Withdrawn |
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 |
| 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 |
| 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.