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Focal One

FDA UDIEUDAMED

Class II (US FDA UDI)

by Edap-Tms France

Identity

Trade Name
Focal One FDA UDI
Generic Name
Physical therapy ultrasound system FDA UDI
Device Name
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. FDA UDI
Model / Reference
TMS 239320 FDA UDI
Description
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. FDA UDI

Identifiers

Primary DI / UDI-DI
03661690000052 FDA UDI
510(k) Number
K172721 FDA UDI
FDA Product Code
PLP FDA UDI
GMDN Term
Physical therapy ultrasound system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.4340 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Physical therapy ultrasound system

Focal One by Edap-Tms France — Class II — MDD, MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Physical therapy ultrasound system.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDD

European Union Unknown

MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Edap-Tms France

Sources (2)

  • FDA UDI f1211e35-f102-4f1b-a767-1201fda7c4a0 35 fields · synced Jun 19, 2026
  • EUDAMED 1 fields · synced Jun 3, 2026