Radiofrequency and Pulsed Electromagnetic Field Treatment of Skin Laxity of the Mon Pubis, Labia and Vaginal Introitus

This is a single-center, open-label, prospective study. Ten (10) subjects that meet the inclusion criteria will be enrolled from the site's pool of patients. Subjects should be a female at the age of 25-65, and have a suitable treatment area (e.g. skin irregularities and/or unwanted skin laxity in the Mons pubis, Introitus and/or Labia area).

Subjects will receive three treatments with the study device, at four week intervals, followed by one month follow-up visits after the last treatment.

Inclusion criteria

• Healthy female between the ages of 25 and 65.
• Able to read, understand and voluntarily provide written Informed Consent;
• Able and willing to comply with the treatment/follow-up schedule and requirements;
• Fitzpatrick skin type I-VI.
• Sexual activity (vaginal intercourse once per month) in a monogamous relationship.
• Women of child-bearing age are required to be using a reliable method of birth control at least 3 months prior to study enrollment, and have a negative Urine Pregnancy test at baseline.
• Women requesting aesthetic benefit to the vaginal mons, introitus and labia.

Exclusion criteria

• Pregnant or intending to become pregnant during the course of study. A urine pregnancy test will be given to women of childbearing potential and performed during initial visit.
• Having any active electrical implant anywhere in the body, such as a pacemaker or an internal defibrillator.
• Having a permanent implant in the treated area.
• Prior use of retinoids in treated area within 2 weeks of initial treatment or during the course of the study.
• Use of oral Isotretinoin (Accutane®) within 6 months of initial treatment or during the course of the study.
• Patient on systemic corticosteroid therapy 6 months prior to and throughout the course of the study.
• Prior skin treatment with laser in treated area within 6 months of initial treatment or during the course of the study.
• Prior use of collagen, fat injections and /or other methods of skin augmentation (enhancement with injected or implanted material) in treated area within 4-6 weeks of initial treatment or during the course of the study. Treatment may not be performed at all over permanent dermal implants.
• Prior ablative resurfacing procedure in treated area with laser or other devices within 12 months of initial treatment or during the course of the study.
• Any other surgery in treated area within 12 months of initial treatment or during the course of the study.
• History of keloid formation or poor wound healing in a previously injured skin area.
• History of epidermal or dermal disorders (particularly if involving collagen or microvascularity).
• Open laceration or abrasion of any sort on the area to be treated.
• Active sexually transmitted disease (e.g. genital Herpes Simplex, condylomata) or vaginosis; any tissue biopsy will be deferred or delayed to a later time point until the infection is resolved.
• Chronic vulvar pain or vulvar dystrophy.
• History of immunosuppression/immune deficiency disorders (including human immunodeficiency virus infection or acquired immune deficiency syndrome) or use of immunosuppressive medications.
• Having any form of active cancer at the time of enrollment and during the course of the study.
• Significant concurrent illness, such as uncontrolled diabetes i.e. any disease state that in the opinion of the Investigator would interfere with the treatment, or healing process.
• Participation in a study of another device or drug within 1 month prior to study enrollment or during this study, and as per the Investigator's careful discretion, as long as not contradictory to any of the above criteria.
• Tattoos in the treatment area.
• Mentally incompetent, prisoner or evidence of active substance or alcohol abuse.
• Having any stage 3-4 cystocele, rectocele, enterocele paravaginal defect or major pelvic organ prolapse beyond the hymenal ring.