Renuvion APR System When Used as an Adjunct Procedure In Gynecomastia Surgery

Inclusion Criteria

• Male subjects, ages 18 - 75 years old.
• ASA Physical Status Classification System Class I and Class II subjects.
• Clinical diagnosis of primary or secondary Gynecomastia.
• Gynecomastia Rohrich Grade IIA or higher.
• Symmetrical gynecomastia Rohrich grades.
• Symmetrical chest measurements (no more than 3% variance between sides).
• Scheduled for Gynecomastia surgery.
• Willing to have Renuvion APR System as an adjunct procedure on one side understanding that an optional balancing procedure may be provided post-study exit.
• Understands and accepts the obligation not to undergo any other procedures or treatments in the areas to be treated during study participation.
• Absence of physical conditions unacceptable to the investigator.
• Willing and able to comply with protocol requirements, including study-required images/photos, assessments/measurements, and returning for follow-up visits.
• Willing to release rights for the use of study photos, including in publication.
• Able to read, understand, sign, and date the informed consent.

Exclusion Criteria

• Subjects without clinical diagnosis of primary Gynecomastia and/or a clinical diagnosis of gynecomastia with secondary causes such as medications, drugs, or testicular tumors.
• Subjects presenting with ASA Physical Status Classification System Classes III or higher.
• Gynecomastia Rohrich Grade I.
• Non-symmetrical gynecomastia Rohrich grades.
• Non-symmetrical chest measurements (more than 3% variance between sides).
• Previous treatment or surgery in the breast area.
• Active systemic or local skin disease that may alter wound healing.
• Significant or uncontrolled medical condition that in the opinion of the investigator participation in the study may compromise the patient's health.
• History of autoimmune disease (excluding Hashimoto's thyroiditis).
• Known susceptibility to keloid formation or hypertrophic scarring.
• Cancerous or pre-cancerous lesions in the area to be treated.
• Possesses a surgically implanted electronic device (i.e. pacemaker).
• Serious mental health illness such as dementia or schizophrenia; psychiatric hospitalization in the past two years.
• Use of endermology post-procedure for the duration of the study.
• Participation in any other investigational study within 30 days prior to consent and throughout study participation.
• Subject who, in the opinion of the investigator, is not an appropriate candidate for the study.