Cleared Traditional

K222226 - EON (FDA 510(k) Clearance)

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

K222226 · Dominion Aesthetic Technologies, Inc. · General & Plastic Surgery device
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Feb 2023
Decision
207d
Days
Class 2
Risk

K222226 is an FDA 510(k) clearance for the EON. 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 February 17, 2023 after a review of 207 days - an extended review cycle.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Dominion Aesthetic Technologies, Inc. devices

Submission Details

510(k) Number K222226 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 2022
Decision Date February 17, 2023
Days to Decision 207 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
93d slower than avg
Panel avg: 114d · This submission: 207d
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
Devices cleared under the same product code (PKT) and FDA review panel - the closest regulatory comparables to K222226.
1060nm laser body slimming machine
K240658 · Hebei JT Medical Co., Ltd. · May 2024
ReBorn (1050nm)
K233962 · Lightfective , Ltd. · Apr 2024
DEKA PHYSIQ 360
K231971 · El.En S.P.A. · Sep 2023
Diode Laser Body Sculpture Systems
K231131 · Shanghai Bele Medical Technology Co.,Ltd · Jun 2023
Diosculpt
K222265 · Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd · Sep 2022
EON
K211681 · Dominion Aesthetic Technologies, Inc. · Mar 2022