Trials / Completed
CompletedNCT04842110
Eon™ FR 1064 Full Abdomen Clinical Study Protocol
A Prospective, Controlled, Standardized, Multi-center, Single-treatment, Single- Arm Evaluation of the EonTM FR 1064 nm Device to Reduce Abdominal Fat
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 26 (actual)
- Sponsor
- Dominion Aesthetic Technologies, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Experimental: eonTM FR 1064 nm device | The subject treatment area - abdomen, was treated with the 1064 nm wavelength laser. |
Timeline
- Start date
- 2019-08-24
- Primary completion
- 2019-12-21
- Completion
- 2019-12-21
- First posted
- 2021-04-13
- Last updated
- 2021-04-13
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04842110. Inclusion in this directory is not an endorsement.