Bausch Health Thermage FXL for Use on Lower Face and Submentum Area

Exclusion Criteria

• •Subject has severe skin laxity in the area of intended treatment which in the opinion of the investigator, may result in an unacceptable aesthetic result.
• •Subject has had a surgical procedure(s) in the area of intended treatment.
• •History of a fat reduction procedure (e.g., liposuction, surgery, lipolytic agents, etc.), in or around the area of intended treatment.
• •Subject needs to administer, or has a known history of subcutaneous injections into the area of intended treatment (e.g., heparin, insulin) within the past month.
• •Currently taking or has taken diet pills or weight control supplements within the past month.
• •Any dermatological conditions, such as scars, infection, in the location of the treatment area that may interfere with the treatment or evaluation.
• •Active implanted device such as a pacemaker, defibrillator, or drug delivery system.
• •Pregnant or intending to become pregnant in the next 6 months.
• •Lactating or has been lactating in the past 6 months.
• •BMI ≥ 35.
• •Unable or unwilling to comply with the study requirements.
• •Currently enrolled in a clinical study of any other unapproved investigational drug or device.
• •Any other condition or laboratory value that would, in the professional opinion of the investigator, potentially affect the subject's response or the integrity of the data or would pose an unacceptable risk to the subject.