FOCAL ONE
High Intensity Ultrasound System For Prostate Tissue Ablation
EDAP Technomed, Inc.
The following data is part of a premarket notification filed by Edap Technomed, Inc. with the FDA for Focal One.
Pre-market Notification Details
| Device ID | K172721 |
| 510k Number | K172721 |
| Device Name: | FOCAL ONE |
| Classification | High Intensity Ultrasound System For Prostate Tissue Ablation |
| Applicant | EDAP Technomed, Inc. 5321 Industrial Oaks Blvd, Suite 110 Austin, TX 78735 |
| Contact | Hugo Embert |
| Correspondent | Hugo Embert EDAP Technomed, Inc. 5321 Industrial Oaks Blvd, Suite 110 Austin, TX 78735 |
| Product Code | PLP |
| CFR Regulation Number | 876.4340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-08 |
| Decision Date | 2018-06-07 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03661690000052 | K172721 | 000 |
| 03661690000243 | K172721 | 000 |
| 03661690000069 | K172721 | 000 |
Trademark Results [FOCAL ONE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 FOCAL ONE 78153657 not registered Dead/Abandoned |
Novartis AG 2002-08-13 |
 FOCAL ONE 78149737 not registered Dead/Abandoned |
Novartis AG 2002-08-01 |
 FOCAL ONE 78127571 2764216 Dead/Cancelled |
Novartis AG 2002-05-09 |
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