Evaluation of Safety and Efficacy of Micro-coring Device for Treatment of Facial Wrinkles and Skin Laxity

• Fitzpatrick Skin Type 1, 2, or 3 as assessed by Investigator

• One or more of the following conditions assessed by Investigator using provided Severity Scales:

  • Nasolabial fold severity at rest ≥2 and ≤4;
  • Marionette line prominence at rest ≥2 and ≤4;
  • Oral commissure drooping at rest ≥2 and ≤4;
  • Jawline sagging at rest ≥2 and ≤4 .
  • Moderate-to-Severe wrinkles at rest at least in one of the following areas - the upper lip, chin and cheeks.

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 or synthetic material injections in the areas to be treated
• Injection of FDA-approved dermal fillers in the past two years
• Injection of fat in the past year
• History of treatment with dermabrasion, ablative laser, or radiofrequency in the past year
• History of treatment with non-ablative laser in the past 6 months
• History of treatment with botulinum toxin injections in the areas to be treated within the prior 6 months
• 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
• Co-morbid condition that in the Investigator's opinion could limit ability to participate in the study or to comply with follow-up requirements
• History of drug and/or alcohol abuse
• Any issue that, at the discretion of the Investigator, would interfere with assessment of safety or efficacy or compromise the subject's ability to undergo study procedures or give informed consent
• Treatment with an investigational device or agent within 30 days before treatment or during the study period