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FDA 510(k)

Focal One®

K-Number: K251910 · 2025-11-19

ApplicantEdap Technomed, Inc.
Decision Date2025-11-19
Product CodePLP
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Focal One® is a medical device manufactured by Edap Technomed, Inc.. It received FDA 510(k) clearance on 2025-11-19 under approval 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. It is manufactured by Edap Technomed, Inc.. The 510(k) number is K251910.

When was Focal One® approved by the FDA?

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

What company makes Focal One®?

Focal One® is manufactured by Edap Technomed, Inc..

What is the FDA product code for Focal One®?

The FDA product code for Focal One® is PLP.

Other Devices by Edap Technomed, Inc.

K172285Ablatherm Fusion K172721FOCAL ONE

Related Devices (Code: PLP)

K160942SonablateSonacare Medical, LLC K172285Ablatherm FusionEdap Technomed, Inc. K172721FOCAL ONEEdap Technomed, Inc. K191200TULSA-PRO SystemProfound Medical, Inc. K202286Tulsa-Pro SystemProfound Medical, Inc. K212150Exablate Prostate SystemInsightec, Inc.

Official Source

View on FDA Database →

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

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