FDA 510(k)

Focal One®

K-Number: K251910 · 2025-11-19

Decision Date2025-11-19

Product CodePLP

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

Focal One® is the device name listed in this FDA 510(k) record. The listed applicant is Edap Technomed, Inc.. It received FDA 510(k) clearance on 2025-11-19 under 510(k) number K251910. The device is classified under product code PLP. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Focal One®?

Focal One® is a medical device that received FDA 510(k) clearance on 2025-11-19. The listed applicant is Edap Technomed, Inc.. The 510(k) number is K251910.

When did Focal One® receive FDA 510(k) clearance?

Focal One® received FDA 510(k) clearance on 2025-11-19, under 510(k) number K251910.

Who is the listed applicant for Focal One®?

The FDA 510(k) record lists Edap Technomed, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Focal One®?

The FDA product code for Focal One® is PLP.

Other records listing Edap Technomed, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K172721FOCAL ONE K172285Ablatherm Fusion

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.