Safety and Efficacy Information
The Science
Our patented Warm LED mechanism of action delivers a unique, high-powered red light, which causes the adipocyte to respond as if you were exercising vigorously. The fat cell’s membrane is disrupted, resulting in temporary pores which allow the fat to escape.
Our patients lose fat permanently through a natural bodily function known as “lipolysis.” The contents of the fat cells are excreted primarily in the patient’s waste, as part of the body’s natural detoxification.
The technology operates at a cellular level and does not generate heat as part of the mechanism of action, but is instead part of an extremely complex, cascading photochemical mechanism.
This technology is rated as Risk Group 1 — the safest category of medical devices. Completely noninvasive and has never shown any side effects and patients do not experience any discomfort.
FDA Clearances and Other Accreditations
Our manufacturer is dedicated to the quality, safety, and effectiveness of our products. We have taken every step to ensure that our systems, processes, services, and products meet and exceed the highest standards for medical device manufacturers set by the International Organization for Standardization.
Accreditations
Our technology has two FDA clearances and is indicated for immediate fat reduction, treatment of the skin, and reduction of pain and inflammation.
Our technology has two FDA clearances and is indicated for immediate fat reduction, treatment of the skin, and reduction of pain and inflammation.
FDA clearances
Our manufacturer has three U.S. patents and has patents pending in 146 countries for our breakthrough invention.
Our manufacturer has three U.S. patents and has patents pending in 146 countries for our breakthrough invention.
