Study to Evaluate the Safety and Efficacy of the Cytrellis Micro-Coring Device for the Treatment of Moderate to Severe Facial Wrinkles

Exclusion Criteria

• •Lesions suspicious for any malignancy or the presence of actinic keratosis, melasma, vitiligo, cutaneous papules/nodules or active inflammatory lesions in the areas to be treated
• •History of keloid formation or hypertrophic scarring
• •History of trauma or surgery to the treatment areas in the past 6 months
• •Scar present in the areas to be treated
• •Silicone injections in the areas to be treated
• •Injection of dermal fillers, fat or botulinum toxin, as well as any minimally invasive/invasive medical device for skin treatment, in the study treatment areas, within the past 6 months (i.e., dermabrasion, laser, RF devices)
• •Active smokers (0.5 pack/day) or having quit within 3 months prior to treatment
• •Active, chronic, or recurrent infection
• •History of compromised immune system or currently being treated with immunosuppressive agents
• •History of sensitivity to analgesic agents, Aquaphor®, topical or local anesthetics (e.g., lidocaine, benzocaine, procaine) or chlorhexidine, povidone-iodine or epinephrine
• •Excessive sun exposure and use of tanning beds or tanning creams within 30 days prior to treatment
• •Treatment with aspirin or other blood thinning agents within 14 days prior to treatment
• •History or presence of any clinically significant bleeding disorder
• •Any issue that, at the discretion of the Investigator, would interfere with assessment of safety or efficacy or compromise the subject's ability to participate in the study
• •Treatment with an investigational device or agent within 30 days before treatment or during the study period