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Eon™ FR 1064 Full Abdomen Clinical Study Protocol

NCT04842110 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2021-04-13

No results posted yet for this study

Summary

This is a marketing study intended to provide additional data for marketing purposes for the eon™ FR is FDA 510(k) which has been cleared for non-invasive lipolysis of the abdomen to achieve disruption of adipocyte cells intended for non-invasive aesthetic use to achieve a desired aesthetic effect. This device is intended for individuals with a Body Mass Index (BMI) of 30 kg/m2 or less.

Conditions

  • Abdominal Obesity

Interventions

DEVICE

Experimental: eonTM FR 1064 nm device

The subject treatment area - abdomen, was treated with the 1064 nm wavelength laser.

Sponsors & Collaborators

  • Dominion Aesthetic Technologies, Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-08-24
Primary Completion
2019-12-21
Completion
2019-12-21
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04842110 on ClinicalTrials.gov