Data / Medical devices / France / EDAP TMS France SA
EDAP TMS France SA: FDA-registered device maker in Vaulx en Velin Rhone, France, 5 510(k) clearances
EDAP TMS France SA is registered with the FDA (registration 9612448) in Vaulx en Velin Rhone, France. It lists 4 device types. The FDA files 5 510(k) clearances under its listings, the newest dated November 19, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9612448
- FEI number
- 3002806876
- Address
- 4 rue du Dauphine, Vaulx en Velin Rhone, France, 69120
- Owner or operator
- EDAP TMS France (8023014)
- Roles
- Complaint file establishment, Foreign private label distributor, Manufacturer, Remanufacturer
- First device listed
- August 8, 2011
- Registered through
- 2026
- Brand names listed
- Ablatherm Integrated Imaging, Focal One, Focal One®, Sonolith I-move, laserlith i-dust
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| High Intensity Ultrasound System For Prostate Tissue Ablation | PLP | 2 | Complaint file establishment, Manufacturer, Remanufacturer | accessdata.fda.gov |
| Lithotriptor, Extracorporeal Shock-Wave, Urological | LNS | 2 | Manufacturer | accessdata.fda.gov |
| Powered Laser Surgical Instrument | GEX | 2 | Foreign private label distributor | accessdata.fda.gov |
| Table, Cystometric, Electric | MMZ | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| November 19, 2025 | K251910 | Focal One® | PLP | Substantially Equivalent | Edap Technomed, Inc. | accessdata.fda.gov |
| June 7, 2018 | K172721 | FOCAL ONE | PLP | Substantially Equivalent | Edap Technomed, Inc. | accessdata.fda.gov |
| October 3, 2017 | K172285 | Ablatherm Fusion | PLP | Substantially Equivalent | Edap Technomed, Inc. | accessdata.fda.gov |
| November 6, 2015 | K153023 | Ablatherm Integrated Imaging | PLP | Substantially Equivalent | Edap Technomed, Inc. | accessdata.fda.gov |
| August 1, 2011 | K111808 | SONOLITH I-MOVE | LNS | Substantially Equivalent | Edap Tms France | accessdata.fda.gov |
Compare with other makers
- All makers of High Intensity Ultrasound System For Prostate Tissue Ablation
- All makers of Powered Laser Surgical Instrument
- All makers of Lithotriptor, Extracorporeal Shock-Wave, Urological
- All makers of Table, Cystometric, Electric
Updated November 19, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.