Focal One
GUDID 03661690000052
The device is a computer-controlled medical device intended to provide High Intensity Focused Ultrasound (also referred to as HIFU) to ablate prostate tissue. The Focal One system consists of the following main sub-assemblies: Focal One Control Module, Dynamic Focal Probe, and consumable Focalpak. HIFU is a unique process of delivering a large amount of heat energy to a confined space in a highly controlled manner. This energy heats the tissue to ablation levels while minimizing the effect on surrounding structures. The ultrasound energy is delivered via an endorectal probe, which includes an imaging system. The ultrasound waves propagate through the rectal wall and are focused on a portion of the prostate, generating intense heat and causing the ablation of tissue within the targeted area. The process is then repeated in a stepwise fashion to destroy the targeted tissues within the prostate. The apex, sphincter and rectum are preserved while prostate tissues are ablated.Imported diagnostic data can be fused with the real time ultrasound image in order to facilitate the targeting of the ablation volume.
EDAP-TMS FRANCE
Physical therapy ultrasound system Physical therapy ultrasound system Physical therapy ultrasound system Physical therapy ultrasound system Physical therapy ultrasound system Physical therapy ultrasound system Physical therapy ultrasound system Physical therapy ultrasound system Physical therapy ultrasound system Physical therapy ultrasound system Physical therapy ultrasound system Physical therapy ultrasound system Physical therapy ultrasound system Physical therapy ultrasound system Physical therapy ultrasound system| Primary Device ID | 03661690000052 |
| NIH Device Record Key | f1211e35-f102-4f1b-a767-1201fda7c4a0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Focal One |
| Version Model Number | TMS 234780 |
| Company DUNS | 383113362 |
| Company Name | EDAP-TMS FRANCE |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +33763346399 |
| agarin@edap-tms.com | |
| Phone | +33763346399 |
| agarin@edap-tms.com | |
| Phone | +33763346399 |
| agarin@edap-tms.com | |
| Phone | +33763346399 |
| agarin@edap-tms.com | |
| Phone | +33763346399 |
| agarin@edap-tms.com | |
| Phone | +33763346399 |
| agarin@edap-tms.com | |
| Phone | +33763346399 |
| agarin@edap-tms.com | |
| Phone | +33763346399 |
| agarin@edap-tms.com | |
| Phone | +33763346399 |
| agarin@edap-tms.com | |
| Phone | +33763346399 |
| agarin@edap-tms.com | |
| Phone | +33763346399 |
| agarin@edap-tms.com | |
| Phone | +33763346399 |
| agarin@edap-tms.com | |
| Phone | +33763346399 |
| agarin@edap-tms.com | |
| Phone | +33763346399 |
| agarin@edap-tms.com | |
| Phone | +33763346399 |
| agarin@edap-tms.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 03661690000052 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K172721
FDA Product Code
| PLP | High Intensity Ultrasound System For Prostate Tissue Ablation |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2020-04-16 |
| Device Publish Date | 2018-06-11 |
Devices Manufactured by EDAP-TMS FRANCE
| 03661690000069 - Focalpak | 2023-09-21 The Focalpak is the single use kit of consumables to support a single patient procedure using the Focal One system which is a co |
| 03661690000243 - FocalPak | 2021-03-12 The Focalpak is the single use kit of consumables to support a single patient procedure using the Focal One system which is a co |
| 03661690000052 - Focal One | 2020-04-16The device is a computer-controlled medical device intended to provide High Intensity Focused Ultrasound (also referred to as HIFU) to ablate prostate tissue. The Focal One system consists of the following main sub-assemblies: Focal One Control Module, Dynamic Focal Probe, and consumable Focalpak. HIFU is a unique process of delivering a large amount of heat energy to a confined space in a highly controlled manner. This energy heats the tissue to ablation levels while minimizing the effect on surrounding structures. The ultrasound energy is delivered via an endorectal probe, which includes an imaging system. The ultrasound waves propagate through the rectal wall and are focused on a portion of the prostate, generating intense heat and causing the ablation of tissue within the targeted area. The process is then repeated in a stepwise fashion to destroy the targeted tissues within the prostate. The apex, sphincter and rectum are preserved while prostate tissues are ablated.Imported diagnostic data can be fused with the real time ultrasound image in order to facilitate the targeting of the ablation volume. |
| 03661690000052 - Focal One | 2020-04-16 The device is a computer-controlled medical device intended to provide High Intensity Focused Ultrasound (also referred to as HI |
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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