Focal One®— 510(k) K251910

Substantially Equivalent

Edap Technomed, Inc.

FDA 510(k) clearance K251910 for Focal One®, Substantially Equivalent on 2025-11-19. Applicant: Edap Technomed, Inc.. Device class: 2.

Clearance details

Applicant: Edap Technomed, Inc.
Product code: Code PLP
Device class: Class 2
Regulation: 21 CFR 876.4340
Advisory panel: Gastroenterology, Urology
Date received: 2025-06-20
Decision date: 2025-11-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Austin, TX, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.