Evaluation of Thermal Outcome and Safety of Nuera Tight RF System

Evaluation of Thermal Outcome and Safety of Nuera Tight RF System

The purpose of the study is to verify tissue heating, temperature stability and safety of the Nuera Tight RF device during and after treatment session applied on the face.

Inclusion Criteria:

• Healthy subjects of either gender, 18 years of age or older
• Subject is able to read, understand and sign an informed consent form
• Subject is willing to comply with all study procedures

Exclusion Criteria:

• Subjects taking medicines that increase skin sensitivity to heat
• Subjects taking medicines that change skin metabolism
• Cancer or any pigmentary or vascular lesions in the planned treatment area
• Subjects with Herpes simplex in the area to be treated
• Pregnant women
• Subjects wearing pacemakers and/or any other type of implanted electronics
• Subjects with any inflammatory skin conditions
• Subjects with active cold sores, open lacerations, abrasions
• Chronic or acute skin infections
• Subjects with active local or systemic infections
• Subjects with any disease in which an increase of skin temperature is contraindicated
• Subjects wearing piercing in the area to be treated
• Subjects have nerve insensitivity to heat in the area to be treated
• Subjects have metal implants in the area to be treated, excluding dental implants
• Subjects allergic to glycerin, paraffin, parfum, parabens, nuts, vegetable oils, calendula, or chamomile
• Any condition where the study investigator determined that the subject is not adequate for this study
• Subjects participating in other studies