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

Erchonia

Status: Completed

Conditions: Circumference Reduction

Treatments: Device: Erchonia Violet Zerona Z6

Study type: Interventional

Funder types: Industry

Identifiers

NCT05674292

R-VZ6

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 25 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

Erchonia Violet Zerona Z6

Experimental group

Description:

405nm violet laser light therapy.

Treatment:

Device: Erchonia Violet Zerona Z6