Cleared Traditional

K180511 - Eon FR (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K180511 · Dominion Aesthetic Technologies, Inc. · General & Plastic Surgery device
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Jun 2019
Decision
470d
Days
Class 2
Risk

K180511 is an FDA 510(k) clearance for the Eon FR. Classified as Laser For Disruption Of Adipocyte Cells For Aesthetic Use (product code PKT), Class II - Special Controls.

Submitted by Dominion Aesthetic Technologies, Inc. (Winter Park, US). The FDA issued a Cleared decision on June 12, 2019 after a review of 470 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.5400 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General & Plastic Surgery submissions.

View all Dominion Aesthetic Technologies, Inc. devices

Submission Details

510(k) Number K180511 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 27, 2018
Decision Date June 12, 2019
Days to Decision 470 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
356d slower than avg
Panel avg: 114d · This submission: 470d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PKT Laser For Disruption Of Adipocyte Cells For Aesthetic Use
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.5400
Definition Laser Intended For The Disruption Of Adipocyte Cells Indicated For Body Contouring Or Reduction In Circumference Of Body Areas.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - PKT Laser For Disruption Of Adipocyte Cells For Aesthetic Use

All 18
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