FocalPak EDP 901400

GUDID 03661690000243

The Focalpak is the single use kit of consumables to support a single patient procedure using the Focal One system which is a computer-controlled medical device intended to provide High Intensity Focused Ultrasound (also referred to as HIFU) to ablate prostate tissue. 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.

EDAP-TMS FRANCE

Customer Support Contacts

Operating and Storage Conditions

Device Identifiers

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172721

FDA Product Code

Sterilization

Device Entry Metadata

On-Brand Devices [FocalPak]