The purpose of this clinical study is to determine the effectiveness of the Erchonia® Violet Zerona Z6 (manufactured by Erchonia Corporation (the Company), an over-the-counter (OTC) laser device, in providing noninvasive body circumference reduction.
The clinical study is an open-label non-inferiority design to evaluate the efficacy of the Erchonia® Violet Zerona Z6, an over-the-counter (OTC) laser device, in providing noninvasive circumference reduction. The clinical study protocol is based on the protocol for the clinical study whose results were submitted in support of clearance of the predicate device, the Erchonia® Zerona® Z6 OTC.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
25
405nm violet diode low level laser device
Tracey Hishon
Bloomfield Hills, Michigan, United States
Jamie Thayer
Marquette, Michigan, United States
Combined Circumference Reduction in Inches of the Waist, Hips, and Bilateral Thighs
Mean change in total combined circumference inches of the waist, hips and bilateral thighs from baseline to endpoint evaluation.
Time frame: 2 weeks
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