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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name High Intensity Ultrasound System For Prostate Tissue Ablation
510(k) Number K251910
Device Name Focal One®
Applicant
Edap Technomed, Inc.
5321 Industrial Oaks Blvd.
Suite 110
Austin,  TX  78735
Applicant Contact Hugo Embert
Correspondent
Hogan Lovells US LLP
1735 Market St., Suite 2300
Philadelphia,  PA  19103
Correspondent Contact Janice Hogan
Regulation Number876.4340
Classification Product Code
PLP  
Date Received06/20/2025
Decision Date 11/19/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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