An Evaluation of the Effect of the Erchonia Corporation Violet Zerona® Z6 for Body Contouring

An Evaluation of the Effect of the Erchonia Corporation Violet Zerona® Z6 for Body Contouring

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.

Inclusion Criteria:

• BMI is 30 or less
• 18 years of age or older

Exclusion Criteria:

• Pregnant
• Open wounds (sores, cuts, ulcers, etc.)
• Individuals with or being treated for any cancerous growth