Treatments and/or Procedures

Study Criteria

Inclusion Criteria:

  1. Signed informed consent to participate in the study.

  2. Scheduled date for surgery (abdominoplasty).

  3. Agree to provide samples for histology from the abdominoplasty.

  4. Female and male subjects, between 18 to 60 years of age at the time of enrollment

  5. Fitzpatrick Skin Type I to VI.

  6. For Contour I V3 treatment only: Abdominal fat thickness of at least 1.5 cm (measured
     by calibrated caliper).

  7. Female subjects must be either post-menopausal, surgically sterilized, or using a
     medically acceptable form of birth control at least 3 months prior to enrollment
     (i.e., oral contraceptives, contraceptive implant, barrier methods with spermicide or
     abstinence).

  8. General good health confirmed by medical history and skin examination of the treated
     area.

  9. Willing to follow the treatment and to provide histology samples during the surgery
     from the intended to be harvested areas.

 10. Willingness to refrain from a change in diet/ exercise/medication regimen for the
     entire course of the study.

 11. Willing to have photographs and images taken of the treated areas to be used (with
     de-identification) in evaluations, publications and presentations

Exclusion Criteria:

A subject is not eligible for participation in this study if he/she meets any of the
following exclusion criteria:

  1. History of hypertension, ischemic heart disease, valvular heart disease, congestive
     heart failure, pacemaker/defibrillator, or abdominal aortic aneurism

  2. Not intended to undergo surgery (abdominoplasty)

  3. Current hyperlipidemia, diabetes mellitus, hepatitis, liver disease, HIV positive
     status, blood coagulopathy or excessive bleeding, autoimmune or connective tissue
     disease

  4. Having or undergoing any form of treatment for active cancer, or having a history of
     skin cancer or any other cancer in the areas to be treated, including presence of
     malignant or pre‐malignant pigmented lesions

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

  6. Having a permanent implant in the treated area, such as metal plates, or an injected
     chemical substance such as silicone

  7. Having undergone any other surgery in the treatment area within 12 months of treatment
     or during the study, including liposuction

  8. Previous body contouring procedures in the treatment area within 12 months

  9. History of skin disease in the treatment area, known tendency to form keloids or poor
     wound healing Known photosensitivity

 10. Suffering from significant skin conditions in the treatment area or inflammatory skin
     conditions, including, but not limited to, open lacerations or abrasions and active
     cold sores or herpes sores prior to treatment (duration of resolution as per the
     Investigator's discretion) or during the treatment course

 11. Skin lesions in the treatment area other than simple nevi on physical examination
     (e.g., atypical nevus, tattoo, abrasions) including depressed scars in the treatment
     area

 12. Very poor skin quality (i.e., severe laxity)

 13. Abdominal wall diastasis or hernia on physical examination

 14. Abnormal kidney, liver or coagulation functions, abnormal lipid profile or blood count
     within the last 3 months

 15. Any acute or chronic condition which, in the opinion of the investigator, could
     interfere with the conduct of the study

 16. Unstable weight within the last 6 months (i.e., more than ± 3% weight change in the
     prior 6 months)

 17. Participation in another clinical study within the last 6 months.

 18. As per the Investigator's discretion, any physical or mental condition which might
     make it unsafe for the subject to participate in this study.