SONOLITH I-MOVE
Lithotriptor, Extracorporeal Shock-wave, Urological
EDAP TMS FRANCE
The following data is part of a premarket notification filed by Edap Tms France with the FDA for Sonolith I-move.
Pre-market Notification Details
| Device ID | K111808 |
| 510k Number | K111808 |
| Device Name: | SONOLITH I-MOVE |
| Classification | Lithotriptor, Extracorporeal Shock-wave, Urological |
| Applicant | EDAP TMS FRANCE COLUMBIA SQUARE 555 THIRTEENTH STREET, NW Washington, DC 20004 |
| Contact | Holstein Howard |
| Correspondent | Holstein Howard EDAP TMS FRANCE COLUMBIA SQUARE 555 THIRTEENTH STREET, NW Washington, DC 20004 |
| Product Code | LNS |
| CFR Regulation Number | 876.5990 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-06-27 |
| Decision Date | 2011-08-01 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03661690000151 | K111808 | 000 |
| 03661690000120 | K111808 | 000 |
| 03661690000113 | K111808 | 000 |
| 03661690000106 | K111808 | 000 |
| 03661690000090 | K111808 | 000 |
Trademark Results [SONOLITH I-MOVE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SONOLITH I-MOVE 79086981 4072469 Live/Registered |
EDAP TMS France 2010-08-16 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.