Histological Study to Assess Safety and Efficacy of the TempSure Firm for Non-Invasive Lipolysis

Histological Study to Assess Safety and Efficacy of the TempSure Firm for Non-Invasive Lipolysis

This is a prospective, open-labeled, non-randomized, multi-center clinical study to collect safety and efficacy data on the TempSure Firm. The intended use of the TempSure device is to use the Firm handpieces for non-invasive lipolysis.

Up to 12 subjects will be enrolled at up to 3 study centers. Subjects will attend a screening/pretreatment visit which may be performed on the same day as the treatment visit. Subjects may receive 1 treatment on the abdomen with the TempSure firm. Subjects will undergo abdominoplasty surgery at one of 4 predetermined timepoint after an abdomen treatment: day 0 (within 24 hours after treatment), 10 days (+/- 3 days), 20 days (+/- 3 days), or 30 days (+/- 7 days). This will be determined by the availability of the subject and/or an as needed basis and this will be decided by the Investigator and the Sponsor.

Inclusion Criteria:

• Male or female between 18 - 55 years old.
• Willing to receive treatments with the TempSure® device and willing to have biopsies taken from a control site and the treatment area (biopsies are collected after the abdominal tissue flap is removed during abdominoplasty surgery)
• Understand and accept obligation not to receive any other procedures on the treatment and control areas throughout the length of the study.
• Understand and accept the obligation and able to be present for all study visits
• Willing to comply with all requirements of the study and able to provide informed consent.

Exclusion Criteria:

Pregnant or of childbearing potential and not using medically effective birth control, or has been pregnant in the last 3 months, currently breast feeding or planning to become pregnant prior to the end of the study.

• Currently enrolled in an investigational drug or device trial, or has received an investigational drug or investigational device treatment(s) in the area to be treated (or designated control area) 6 months prior to entering this study (or at the discretion of the Investigator) .
• Cuts, wounds, or infected skin on the area to be treated or designated control area
• On local, oral, or systemic anesthetic agents.
• Condition(s) or circumstance(s) that, in the investigators opinion, may put the subject at significant risk, may confound study results or may interfere significantly with subject participation.