Study of Over-The-Counter Use of Low Level Laser Light Therapy for Body Contouring of the Waist, Hips and Thighs

Evaluation of Efficacy, Usability and Labeling Comprehension for Over-the-Counter Use of the Erchonia Corporation ZERONA® Z6 for Body Contouring of the Waist, Hips and Thighs

The purpose of this study is to test the ability of the lay end user to understand the information contained in the User's Guide; to correctly identify patients who are suitably qualified to receive treatment; and to correctly administer the treatment with the Erchonia ZERONA® Z6 for circumference reduction of the waist, hips and thighs in an over-the-counter setting.

The Erchonia ZERONA® Z6 is a low level laser light therapy device that has been approved by the United States Food and Drug Administration (FDA) for use by licensed medical professionals to help to reduce the circumference of the hips, waist and thighs.

This study is to see if the Erchonia ZERONA® Z6 can be used by lay (non-medical professional) people to treat others to help to reduce the circumference of the hips, waist and thighs.

Lay End Users

Inclusion Criteria:

• 18 years of age or older
• Able to read and write English.
• Employees of the study test sites

Treatment Subjects

Inclusion Criteria

• 18 years of age or older
• Body Mass Index (BMI) <= 30 kg/m2

Exclusion Criteria

• Pregnancy
• Open wounds (sores, cuts, ulcers, etc.) on or around the waist, hips and/or thighs
• Currently have or are being treated for any cancerous growths on or around the waist, hips and/or thighs