This clinical trial has been set forth to determine the safety and efficacy of Thienna's Xtreme Lip-Shaper® System as a home-use cosmetic device for lip enhancement.
This study's protocol/procedures/research had been approved by the International
Review Board (IRB). The (IRB) is regulated by the Food and Drug Administration (FDA) and is oversight by the Department of Health and Human Services (HHS). To learn more about FDA 101: Clinical Trials and Institutional Review Boards, you can visit: