Clinical Evaluation of RFAL of Breast Envelope and NAC Position

The purpose of this study is to evaluate the safety and efficacy of RFAL for the Breast Envelope and Nipple-Areolar Complex (NAC) Position as measured by Vectra 3D circumferential imaging system (Canfield, NJ)

Inclusion criteria

• Informed consent agreement signed by the subject.
• Healthy females 21 to 60 years of age.
• Presence of grade I-III Breast Ptosis, mastopexy with history of breast augmentation, correction of asymmetry, mastopexy alone, mastopexy following implant removal and modest breast reduction in combination with or without lipoaspiration.
• Post-menopausal or surgically sterilized or using a medically acceptable form of birth control at least 3 months prior to enrollment and during the entire course of the study (i.e., oral contraceptives, IUD, contraceptive implant, barrier methods with spermicide, or abstinence).
• Willingness to follow the treatment and follow-up schedule and the post-treatment care.
• All participants must have a recorded mammogram before the beginning of the study.

Exclusion criteria

• Pacemaker or internal defibrillator, or any other active electrical implant anywhere in the body.
• Permanent implant in the treated area such as metal plates and screws, silicone implants or an injected chemical substance.
• Current or history of skin cancer (remission of 5 years), or current condition of any other type of cancer, or pre-malignant moles.
• Severe concurrent conditions, such as cardiac disorders, epilepsy, uncontrolled hypertension, and liver or kidney diseases.
• History of bleeding coagulopathies or use of anticoagulants in the last 2 weeks.
• Impaired immune system due to immunosuppressive diseases such as AIDS and HIV or use of immunosuppressive medications.
• Poorly controlled endocrine disorders, such as diabetes or thyroid dysfunction.
• Any active condition in the treatment area, such as sores, psoriasis, eczema, and rash.
• History of skin disorders, keloids, abnormal wound healing, as well as very dry and fragile skin.
• Use of Isotretinoin (Accutane®) within 6 months prior to treatment.
• Significant systemic illness or occult systemic illness.
• Illness, infection or skin diseases localized in area of treatment.
• Other therapies or medication which may interfere with treatment.
• Breastfeeding, pregnant, or planning to become pregnant during the study.
• Allergy to lidocaine or other anaesthesia.
• Recent surgery in treatment area within the past 6 months.
• Participation in a study of another device or drug within 3 months prior to enrolment or during this study.
• As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the patient to participate in this study.
• As per the practitioner's discretion, refrain from treating any condition that might make it unsafe for the patient.