Evaluation of the Use of the Renuvion APR System in the Labia

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 ortreatments 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 anapproved method of birth control during study participation.

• Willing and able to comply with protocol requirements, including study-requiredimages/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 orhigher.

• 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 theinvestigator 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; psychiatrichospitalization in the past two years.

• Participation in any other investigational study within 30 days prior to consent andthroughout study participation.

• Subject who, in the opinion of the investigator, is not an appropriate candidate forthe study.