Peri-orbital and Peri-oral Wrinkle Reduction Trial

Exclusion Criteria

• •Presence of an active systemic or local skin disease that may affect wound healing.
• •BMI equal to or greater than 25
• •Severe solar elastosis.
• •Excessive subcutaneous fat in the area(s) to be treated.
• •Mild or severe skin laxity on the area(s) to be treated.
• •Significant scarring in the area(s) to be treated.
• •Open wounds or lesions in the area(s) to be treated.
• •Severe or cystic acne on the area(s) to be treated.
• •Active implantables (e.g., pacemakers or defibrillators) or metallic implants in the treatment area.
• •Inability to understand the protocol or to give informed consent.
• •Microdermabrasion, or prescription level glycolic acid treatment to the treatment area(s) within 4 weeks prior to study participation or during the study.
• •Marked asymmetry, ptosis, excessive dermatochalasis, deep dermal scarring, or thick sebaceous skin in the area(s) to be treated.
• •History of chronic drug or alcohol abuse.
• •History of autoimmune disease.
• •History of Bell's Palsy or epilepsy.
• •History of diabetes.
• •Has a known allergy, or a known history of sensitivity, to lidocaine, tetracaine, para-aminobenzoic acid (PABA).
• •Concomitant therapy that, in the investigator's opinion, would interfere with the evaluation of the safety or efficacy of the study device.
• •Subjects who anticipate the need for surgery or overnight hospitalization during the study.
• •Subjects who, in the investigator's opinion, have a history of poor cooperation, noncompliance with medical treatment, or unreliability.
• •Concurrent enrollment in any study involving the use of investigational devices or drugs.
• •Current smoker or history of smoking in the last five years.
• •History of the following cosmetic treatments in the area(s) to be treated:
• •1. Skin tightening procedure within the past year;
• •2. Injectable fillers of any type within the past 12 or 24 months, depending on type;
• •3. Neurotoxins within the past six months;
• •4. Ablative resurfacing laser treatment;
• •5. Nonablative, rejuvenative laser or light treatment within the past six months;
• •6. Surgical dermabrasion or deep facial peels;
• •7. Facelift, blepharoplasty, or browlift within the past 2 years; or
• •8. Any history of contour threads.
• •History of using the following prescription medications:
• •1. Accutane or other systemic retinoids within the past six months;
• •2. Topical Retinoids within the past four weeks;
• •3. Antiplatelet agents/Anticoagulants;
• •4. Psychiatric drugs that in the investigators opinion would impair the subject from understanding the protocol requirements or understanding and signing the informed consent.