Evaluation of the Safety and Efficacy of the NuEra Tight VRF for the Treatment of Vaginal and Vulvar Tissue Laxity

Inclusion Criteria: * Women age between 35 to 60 * Last vaginal delivery is at least 12 months prior to enrollment * Self-reported vaginal laxity defined as "very loose," "moderately loose," or "slightly loose" on the Vaginal Laxity Questionnaire (VLQ) * Sexual activity≥ once per month, with a same partner * Willing to use contraception for the duration of the study * Negative urine analysis * Negative pregnancy test * Patient is not pregnant nor planning to become pregnant throughout the duration of the study * Willing to improve vaginal lips / genitals appearance (optional) * Normal gynecological exam from the recent year * If taking probiotics and/or any other supplement or suppository as part of daily regimen, willing to maintain same regimen throughout the entire duration of the study * Able and willing to comply with the treatment/follow-up schedule and requirements · * Willing to sign an informed consent Exclusion Criteria: * Previous pelvic floor reconstructive surgery with mesh. * Pelvic organ prolapse (POP) \>II according to the pelvic organ prolapse quantification system * Pregnant or lactating * Women in post-menopausal stage for more than five years. * Active genital infection or sexually transmitted diseases * Subject presenting abnormal Pap smear result from the last five years with any of the following findings according to the Bethesda System (2001) classification: A.. Atypical Squamous Cells-cannot exclude high grade squamous intraepithelial lesion B. Atypical Glandular Cells (Endocervical, Endometrial not otherwise specified) C. High Grade squamous intraepithelial lesion (HSIL)D. Carcinoma * Patients with implantable devices, such as but not limited to pacemakers, implanted defibrillators, and Cochlear ear implant * Serious systemic disease or any chronic condition that could interfere with study compliance * Has metal implant(s) within the treated area, such as surgical clips, plates and screws, intrauterine device (IUD) or artificial joints * History of diseases stimulated by heat, such as recurrent herpes zoster in the treatment area, unless treatment is conducted following a prophylactic regimen. * History of vaginal tissue disease in the treatment area * Taken part in a clinical trial involving an investigational drug or device within 30 days prior to screening and through the study duration * Presence of Vulvar lesions or any other reason that, in the opinion of the investigator, prevents the subject from participating in the study or compromise the subject safety * Nerve insensitivity to heat anywhere in the treatment area, since ongoing feedback by a patient during a procedure is required * Previous treatment with a vaginal energy based device, including laser treatment. * Any other reason that, in the opinion of the investigator, prevents the subject from participating in the study or compromise the subject safety