FDA 510(k)

EON

K-Number: K211681 · 2022-03-30

ApplicantDominion Aesthetic Technologies, Inc.

Decision Date2022-03-30

Product CodePKT

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

EON 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 2022-03-30 under 510(k) number K211681. 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?

EON is a medical device that received FDA 510(k) clearance on 2022-03-30. The listed applicant is Dominion Aesthetic Technologies, Inc.. The 510(k) number is K211681.

When did EON receive FDA 510(k) clearance?

EON received FDA 510(k) clearance on 2022-03-30, under 510(k) number K211681.

Who is the listed applicant for EON?

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?

The FDA product code for EON 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.

K222226EON K180511Eon FR

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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.