Safety and Efficacy of Cryolipolysis Clinical Protocols

Inclusion Criteria:

• The participant (healthy volunteer) who has read and signed the informed consentform for the study.

• Male or female ≥ 22 years and ≤ 65 years of age.

• Subjects with a body mass index (BMI) of 30 or less and who have a greater volume ofadipose tissue in the abdomen (except precordial region) and flanks.

• Subject has not changed in weight more than 5% of body weight in the previous month.

• Subject agrees to maintain his/her weight (i.e., within 5%) by not making majorchanges in his/her diet or exercise routine during the study.

• Subject agrees to have photographs taken of the treatment area(s) during thescheduled periods.

Exclusion Criteria:

• Diabetes mellitus or need to administer or known history of subcutaneous injectionsin the area of intended treatment (e.g. heparin, insulin) in the last month;

• Metabolic and/or liver diseases that compromise vitamin metabolism;

• Being pregnant or planning to become pregnant during the study period (within thenext 8 months);

• Being breast-feeding or having breast-fed in the last 6 months;

• Having a known sensitivity to cold, such as cold urticaria, Raynaud's disease,chilblains (pernio) or any known condition with a response to cold exposure thatlimits blood flow to the skin;

• Irritated skin or presence of dermatitis;

• Keloids or propensity for keloids in the area to be treated;

• Having a history of hernia in the area(s) to be treated.

• Any dermatological conditions, such as moderate to excessive skin laxity, orscarring at the location of the treatment sites that may interfere with treatment orevaluation (stretch marks are not an exclusion);

• Have a history of a bleeding disorder or are taking any medications that, in theopinion of the investigator, may increase the risk of bruising;

• Recent surgery at the treatment site;

• Regular use of anti-inflammatory medications;

• Are taking or have taken any pills or dietary supplements within the past month.

• Invasive fat reduction procedure (e.g., liposuction, mesotherapy) in the intendedtreatment area;

• Implanted electronic devices (e.g., pacemaker);

• Are currently enrolled in a clinical trial of any unapproved investigational drug ordevice.

• Any other condition or laboratory value that could, in the professional opinion ofthe investigator, potentially affect the subject's response or the integrity of thedata or pose an unacceptable risk to the subject.