Non-invasive Improvement of Buttocks With Magnetic Device
Non-invasive Improvement of Buttocks With Magnetic Device
This study will evaluate the clinical safety and patient satisfaction with the high power
 magnet system for the aesthetic improvement of buttocks. The study is a prospective
 multi-center open-label single-arm study. The subjects will be enrolled and assigned into a
 single study group. Subjects will be required to complete four (4) treatment visits and three
 follow-up visits - 1 month, 3 months and 12 months after the final treatment. Study will be
 conducted at several study sites.

 At the baseline visit, subject's weight will be recorded.

 The treatment administration phase will consist of four (4) treatments, delivered twice a
 week. The applicator will be applied over the gluteal area. Visible contractions will be
 induced by the device.

 At the last therapy visit, the subject's weight will be recorded. In addition, subjects will
 receive Subject Satisfaction Questionnaire to fill in.

 Safety measures will include documentation of adverse events (AE) including subject's
 experience of pain or discomfort after the procedure. Following each treatment administration
 and at the follow-up visits, subjects will be checked for immediate post-procedure adverse
 event assessment.

 Post-procedure evaluation (follow-up visits) will be conducted 1 month, 3 months and 12
 months after the final treatment. A weight measure will be conducted. Also, subject's
 satisfaction will be noted.
Inclusion Criteria:

 -  Voluntarily signed informed consent form

 -  BMI ≤ 30 kg/m2

 -  Women of child-bearing potential are required to use birth control measures during the
 whole duration of the study

 -  Subjects willing and able to abstain from partaking in any treatments other than the
 study procedure to promote body contouring during study participation

 -  Subjects willing and able to maintain his/her regular (pre-procedure) diet and
 exercise regimen without effecting significant change in either direction during study
 participation

 Exclusion Criteria:

 -  Cardiac pacemakers

 -  Electronic implants

 -  Pulmonary insufficiency

 -  Metal implants

 -  Drug pumps

 -  Haemorrhagic conditions

 -  Anticoagulation therapy

 -  Heart disorders

 -  Malignant tumor

 -  Fever

 -  Pregnancy

 -  Breastfeeding

 -  Following recent surgical procedures when muscle contraction may disrupt the healing
 process

 -  Application over menstruating uterus

 -  Application over areas of the skin which lack normal sensation

 -  Scars, open lesions and wounds at the treatment area

 -  Unrepaired abdominal hernia