Pilot Study for the Clinical Evaluation of Mechanical Coring to Achieve Directional Skin Tightening
The objective of this clinical study is to evaluate the safety and efficacy of mechanical coring for directional skin tightening. This study is a prospective, up to 3 center, multiple skin treatment area study of the safety and efficacy of mechanical coring with directional closure to achieve directional skin tightening.
• Healthy, male or female subjects between 30 and 70 years of age.
• Able to read, understand, and voluntarily provide written Informed Consent.
• Able and willing to comply with the treatment/follow-up schedule and requirements.
• Women of childbearing age are required to be using a reliable method of birth control at least 3 months prior to study enrollment and for the duration of the study and have a negative Urine Pregnancy test at baseline.
• Subjects may have any Fitzpatrick skin type, however, no more than 35% of subjects may have Fitzpatrick skin type V or VI.