Robotic Mechanical Coring for the Treatment of Moderate to Severe Facial Wrinkles

Eligibility Criteria

• 1. Male or female subjects between 22 and 75 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. Fitzpatrick skin type I to IV.
• 6. Cheek areas are at least a score of 3 using the Lemperle Wrinkle Scale as judged by the Investigator.
• 1. Previous aesthetic (device and/or surgical) skin treatment (injection of dermal fillers, fat, or botulinum toxin), in the treated areas in the last 6 months.
• 2. Silicone, Tattoos, body jewelry, that cannot be removed for the duration of treatment and/or any other synthetic material in the treatment area.
• 3. Any type of scar in the treatment area
• 4. Excessive sun exposure and use of tanning beds or tanning creams within 30 days to prior to treatment.
• 5. History of keloid formation or hypertrophic scarring.
• 6. Active smoker or having quit smoking in the last 3 months.
• 7. Active, chronic, or recurrent infection including Herpes simplex virus (HSV) infection or history of HSV in the last 6 months.
• 8. Compromised immune and/or healing system (e.g., poorly controlled diabetes, collagen vascular disease or autoimmune diseases such as scleroderma, morphea, etc.).
• 9. Hypersensitivity/allergy to analgesic agents, Betadine, tumescent, Tegaderm or tensioning tape that will be used in the study.
• 10. Co-morbid condition that could limit the ability of the subject to participate in the study or to comply with follow-up requirements.
• 11. Pregnant, planning pregnancy during the trial course or breastfeeding.
• 12. History of bleeding disorder or taking medication that can potentially increase bleeding including anticoagulation.
• 13. Carcinoma, melanoma, or any other cutaneous cancerous condition in the last 6 months.
• 14. Non-cancerous lesions (e.g. actinic keratosis, vitiligo, cutaneous papules, nodules, active inflammatory lesions) in the region to be treated.
• 15. Currently or in the last 1-month part of another clinical study of an investigational drug and/or experimental medical device.
• 16. Any medical condition that, at the discretion of the investigator, would hamper the impact or the healing process and contra-indicate the subject's participation.