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This is a marketing study intended to provide additional data for marketing purposes for the eonâ„¢ 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1064 Full Abdomen | Experimental | eonTM FR 1064 nm device Patient will be treated with the eonTM FR 1064 nm device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental: eonTM FR 1064 nm device | Device | The subject treatment area - abdomen, was treated with the 1064 nm wavelength laser. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Photographic Evaluations as a Measure of Effectiveness | Photographs of the treatment area will be obtained at baseline and 12 weeks post treatment and be evaluated by blinded independent readers to correctly identify pre-treatment (baseline) photographs compared to 12 weeks post treatment photographs in order to determine effectiveness of device. | 12 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Adipose Layer Thickness | Ultrasound measurements of adipose layer thickness will be collected at baseline and 12 weeks after procedure to evaluate changes between both. | 12 weeks |
| Subject Satisfaction |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fiala Aesthetics | Altamonte Springs | Florida | 32701 | United States |
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| ID | Term |
|---|---|
| D056128 | Obesity, Abdominal |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
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Subject Questionnaires will be completed by subjects at the end of study to determine the subject satisfaction with procedure.
| 12 weeks |
| D009750 |
| Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |