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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 the device name listed in this FDA 510(k) record. The listed applicant is Edap Technomed, Inc.. It received FDA 510(k) clearance on 2018-06-07 under 510(k) 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. The listed applicant is Edap Technomed, Inc.. The 510(k) number is K172721.

When did FOCAL ONE receive FDA 510(k) clearance?

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

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.

K251910Focal One®K172285Ablatherm Fusion

Related Devices (Code: PLP)

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.

K251910Focal One®Edap Technomed, Inc.K240296Tulsa Pro System (Pad-105)Profound Medical, Inc.K231378Exablate Model 2100V1, Exablate Prostate System, Exablate MRgFUS, Exablate 2100V1 Type 3.0Insightec, Ltd.K230692TULSA-PRO SystemProfound Medical, Inc.K211858TULSA-PRO SystemProfound Medical, Inc.K212150Exablate Prostate SystemInsightec, Inc.

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.

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