Low-Frequency, High-Intensity Ultrasound for Waist Circumference Reduction

Exclusion Criteria

• •Age equal to or below 17.
• •Body Mass Index \< 25.
• •Open sores, wounds, or otherwise compromised skin in the treatment area
• •History of keloid formation, hypertrophic scarring, or abnormal/delayed wound healing.
• •Known or suspected pregnancy, or active nursing.
• •General systemic conditions of arteriosclerosis, anemia, aortic aneurysm, or hypertension.
• •Liver conditions such as hyperlipidemia, hepatitis, liver disease, or abnormal liver function.
• •Diabetes or blood-glucose sensitivity
• •Any prior invasive cosmetic surgery to the waist or abdominal area, such as liposuction.
• •Hernias or diastasis recti within the treatment area.
• •Concurrent, or within the last 6 months, participation in any clinical trial for another device or drug.
• •Existing bacterial or viral infections (influenza, rhinovirus, hepatitis, pneumonia, tuberculosis, and the like)
• •Presence of acne vulgaris, herpes zoster, psoriasis vulgaris, or similar skin conditions in the treatment area.
• •Any type of cosmetic treatment to the target area within the last 6 months.
• •Implanted active medical device anywhere in the subject, or metallic or polymeric implants in the vicinity of the treatment area.
• •Currently undergoing, or recently underwent, chemotherapy or radiation treatment.
• •Per the investigator's discretion, any physical or mental condition which may compromise the patient's safety or welfare.
• •Failure to complete the study as outlined.