New device tested for labia reduction in small study

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Female subjects, ages 35 - 70 years old. * ASA Physical Status Classification System Class I and Class II subjects. * Labial protrusion Class II and Class III (MOTAKEF scale)12. * Females who do not desire traditional invasive surgery. * 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. * Females of childbearing potential who are sexually active must be willing to use an approved method of birth control during study participation. * 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: * Labial protrusion Class I (MOTAKEF scale). * Subjects presenting with ASA Physical Status Classification System Classes III or higher. * Pregnant, lactating, or plans to become pregnant during study participation. * Known hypersensitivity or allergy to tumescent anesthetic (lidocaine/ epinephrine). * Previous treatment in the study treatment 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. * 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. * 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.