Mechanical Coring to Achieve Directional Skin Tightening

Eligibility Criteria

• 1. Healthy, male or female subjects between 30 and 70 years of age.
• 2. Able to read, understand, and voluntarily provide written Informed Consent.
• 3. Able and willing to comply with the treatment/follow-up schedule and requirements.
• 4. 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.
• 5. Subjects may have any Fitzpatrick skin type, however, no more than 35% of subjects may have Fitzpatrick skin type V or VI.
• 1. Previous aesthetic (device and/or surgical) skin treatment in the treated areas (under arms and/or behind the ear) in the previous 6 months.
• 2. Fat, collagen, silicone, tattoos, body jewelry, that cannot be removed for the duration of treatment, and tegaderm/glue application or any other synthetic material in the treatment area.
• 3. History of keloid formation
• 4. Active smoker or having quit smoking in the last 3 months.
• 5. Active, chronic, or recurrent infection
• 6. Compromised immune and/or healing system (e.g. diabetes)
• 7. Hypersensitivity/allergy to analgesic agents, Betadine, tumescent, Benzoin Tincture, Tegaderm or tensioning tape that will be used in the study.
• 8. Co-morbid condition that could limit the ability to participate in the study or to comply with follow-up requirements.
• 9. Pregnant or breastfeeding
• 10. Any indication that may cause excessive bleeding, e.g., anticoagulants.
• 11. Carcinoma, melanoma, or any other cancerous condition in the last 6 months.
• 12. Allergy to adrenaline, epinephrine, or Tranexamic acid (TXA).
• 13. Currently or in the last 1-month part of another clinical study of an investigational drug and/or experimental medical device
• 14. Any issue that, at the discretion of the investigator would contra-indicate the subject's participation.