Eon FR— 510(k) K180511

Substantially Equivalent

Dominion Aesthetic Technologies, Inc.

FDA 510(k) clearance K180511 for Eon FR, Substantially Equivalent on 2019-06-12. Applicant: Dominion Aesthetic Technologies, Inc.. Device class: 2.

Clearance details

Applicant: Dominion Aesthetic Technologies, Inc.
Product code: Code PKT
Device class: Class 2
Regulation: 21 CFR 878.5400
Advisory panel: General, Plastic Surgery
Date received: 2018-02-27
Decision date: 2019-06-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Winter Park, FL, US

Download summary PDF View on FDA.gov ↗

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