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

Exclusion Criteria

• •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.