NCT05674292

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Erchonia Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Circumference Reduction

Interventions

Type	Name	Description
DEVICE	Erchonia Violet Zerona Z6	405nm violet diode low level laser device

Timeline

• Start date: 2022-07-11
• Primary completion: 2023-03-28
• Completion: 2023-03-28
• First posted: 2023-01-06
• Last updated: 2023-09-13
• Results posted: 2023-09-13

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study