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FDA 510(k)

Eon FR

K-Number: K180511 · 2019-06-12

ApplicantDominion Aesthetic Technologies, Inc.
Decision Date2019-06-12
Product CodePKT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Eon FR is the device name listed in this FDA 510(k) record. The listed applicant is Dominion Aesthetic Technologies, Inc.. It received FDA 510(k) clearance on 2019-06-12 under 510(k) number K180511. The device is classified under product code PKT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Eon FR?

Eon FR is a medical device that received FDA 510(k) clearance on 2019-06-12. The listed applicant is Dominion Aesthetic Technologies, Inc.. The 510(k) number is K180511.

When did Eon FR receive FDA 510(k) clearance?

Eon FR received FDA 510(k) clearance on 2019-06-12, under 510(k) number K180511.

Who is the listed applicant for Eon FR?

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

What is the FDA product code for Eon FR?

The FDA product code for Eon FR is PKT.

Other records listing Dominion Aesthetic Technologies, 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.

K222226EONK211681EON

Related Devices (Code: PKT)

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.

K2406581060nm laser body slimming machineHebei JT Medical Co., Ltd.K233962ReBorn (1050nm)Lightfective , Ltd.K231971DEKA PHYSIQ 360El.En S.P.A.K231131Diode Laser Body Sculpture SystemsShanghai Bele Medical Technology Co.,LtdK222226EONDominion Aesthetic Technologies, Inc.K222265DiosculptShanghai Wonderful Opto-Electrics Tech.Co.,Ltd

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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