Cleared Traditional

K211681 - EON (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence.

K211681 · Dominion Aesthetic Technologies, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2022
Decision
302d
Days
Class 2
Risk

K211681 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 March 30, 2022 after a review of 302 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: Standard predicate-based submission. Elevated predicate reliance profile. 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 K211681 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 2021
Decision Date March 30, 2022
Days to Decision 302 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
188d slower than avg
Panel avg: 114d · This submission: 302d
Pathway characteristics
Predicate-based equivalence.

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most General & Plastic Surgery devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT04797988 Completed Interventional Industry-sponsored

Eon® Flanks Safety Clinical Study Protocol

11
Patients (actual)
1
Site
Treatment
Purpose
Open label
Masking
Condition studied Adipose Tissue
Study design Single group
Eligibility All sexes · 18 Years+ · Healthy volunteers accepted
Sponsor Dominion Aesthetic Technologies, Inc. (industry)
Started 2021-02-06 → Primary completion 2021-05-15
Primary outcome
Safety Evaluation eon® treatment of the flanks (Adverse Events)
Secondary outcome
Subject Satisfaction
Study completed - no results published. This trial concluded in 2021 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished. Individual participant data will not be shared.
View full study on ClinicalTrials.gov

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 K211681.
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
EON
K222226 · Dominion Aesthetic Technologies, Inc. · Feb 2023
Diosculpt
K222265 · Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd · Sep 2022