An Evaluation of the Erchonia Laser As a Non-Invasive Treatment to Improve the Appearance of Skin Laxity

Exclusion Criteria

• •Skin laxity resulting from genetic disorders, including but not limited to Ehlers-Danlos Syndrome.
• •History of undergoing a fat reduction procedure (e.g., liposuction, bariatric surgery, abdominoplasty).
• •Botulinum toxin or other aesthetic drug injections within the abdomen area within the past 6 months.
• •History of any major prior surgery in the abdominal area
• •Implanted medical prostheses (such as clips, pins or plates) in or adjacent to the area of intended treatment.
• •Active implanted device such as a pacemaker, defibrillator, or drug delivery system.
• •Any clinical and significant dermatological skin condition(s) in the intended abdominal treatment area, such as skin infections or rashes, extensive scarring, psoriasis, etc..
• •Tattoo or former tattoo at the treatment area.
• •Current moderate to heavy tobacco use, defined as smoking 10 or more cigarettes per day (or equivalent use of other nicotine-containing products such as cigars, pipes, chewing tobacco, or e-cigarettes) within the past 6 months
• •History of chronic drug or alcohol abuse.
• •Pregnant or intending to become pregnant in the next 6 months.
• •Currently enrolled in a clinical study of an unapproved investigational drug or device.