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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 a medical device manufactured by Dominion Aesthetic Technologies, Inc.. It received FDA 510(k) clearance on 2019-06-12 under approval 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. It is manufactured by Dominion Aesthetic Technologies, Inc.. The 510(k) number is K180511.

When was Eon FR approved by the FDA?

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

What company makes Eon FR?

Eon FR is manufactured by Dominion Aesthetic Technologies, Inc..

What is the FDA product code for Eon FR?

The FDA product code for Eon FR is PKT.

Other Devices by Dominion Aesthetic Technologies, Inc.

K211681EON K222226EON

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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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