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:

1. Healthy female between the ages of 25 and 65.

2. Able to read, understand and voluntarily provide written Informed Consent;

3. Able and willing to comply with the treatment/follow-up schedule and requirements;

4. Fitzpatrick skin type I-VI.

5. Sexual activity (vaginal intercourse once per month) in a monogamous relationship.

6. 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.

7. Women requesting aesthetic benefit to the vaginal mons, introitus and labia.

Exclusion Criteria:

1. 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.

2. Having any active electrical implant anywhere in the body, such as a pacemaker or an
internal defibrillator.

3. Having a permanent implant in the treated area.

4. Prior use of retinoids in treated area within 2 weeks of initial treatment or during
the course of the study.

5. Use of oral Isotretinoin (Accutane®) within 6 months of initial treatment or during
the course of the study.

6. Patient on systemic corticosteroid therapy 6 months prior to and throughout the course
of the study.

7. Prior skin treatment with laser in treated area within 6 months of initial treatment
or during the course of the study.

8. 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.

9. 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.

10. Any other surgery in treated area within 12 months of initial treatment or during the
course of the study.

11. History of keloid formation or poor wound healing in a previously injured skin area.

12. History of epidermal or dermal disorders (particularly if involving collagen or
microvascularity).

13. Open laceration or abrasion of any sort on the area to be treated.

14. 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.

15. Chronic vulvar pain or vulvar dystrophy.

16. History of immunosuppression/immune deficiency disorders (including human
immunodeficiency virus infection or acquired immune deficiency syndrome) or use of
immunosuppressive medications.

17. Having any form of active cancer at the time of enrollment and during the course of
the study.

18. 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.

19. 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.

20. Tattoos in the treatment area.

21. Mentally incompetent, prisoner or evidence of active substance or alcohol abuse.

22. Having any stage 3-4 cystocele, rectocele, enterocele paravaginal defect or major
pelvic organ prolapse beyond the hymenal ring.