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FDA 510(k)

FOCAL ONE

K-Number: K172721 · 2018-06-07

ApplicantEdap Technomed, Inc.
Decision Date2018-06-07
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 2018-06-07 under approval number K172721. 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 2018-06-07. It is manufactured by Edap Technomed, Inc.. The 510(k) number is K172721.

When was FOCAL ONE approved by the FDA?

FOCAL ONE received FDA 510(k) clearance on 2018-06-07, under approval number K172721.

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 K251910Focal One®

Related Devices (Code: PLP)

K160942SonablateSonacare Medical, LLC K172285Ablatherm FusionEdap Technomed, Inc. K191200TULSA-PRO SystemProfound Medical, Inc. K202286Tulsa-Pro SystemProfound Medical, Inc. K212150Exablate Prostate SystemInsightec, Inc. K211858TULSA-PRO SystemProfound Medical, 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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