Evaluation of the Efficacy and Safety of PiQo4 for Facial Skin Rejuvenation

Exclusion Criteria

• •Any of the following will exclude the subject from the study:
• •Pregnant, intending to become pregnant during the course of study, less than 3 months postpartum or less than 3 months after completion of breastfeeding
• •Prior skin laser, light or other energy device treatment in treated area within 6 months of initial treatment or during the course of the study.
• •Known hypersensitivity or contraindications to anesthetic agents including lidocaine and its derivatives, and Toradol.
• •Having a history of diseases stimulated by heat, such as recurrent Herpes Simplex in the treated area, unless treatment is conducted following a prophylactic regimen.
• •History of post inflammatory pigmentary disorders, particularly a tendency for hyper- or hypo-pigmentation.
• •Having Melasma.
• •Having multiple dysplastic Nevi in are to be treated.
• •Having an excessive underlying vascular conditions (e.g. dense network of capillaries).
• •History of keloid scarring or of abnormal wound healing.
• •Suffering from current or history of significant skin conditions in the treated area or inflammatory skin conditions.
• •History of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or currently using immunosuppressive medications.
• •Having a known anticoagulative or thromboembolic condition or taking anticoagulation medications one week prior to and during the treatment course (to allow inclusion, temporary cessation of use as per the subject's physician's discretion).
• •Having a neurological disorder (including Multiple Sclerosis, Parkinson's disease).
• •Having seizure disorder.
• •Having fibromyalgia.
• •Excessively tanned in areas to be treated or unable/unlikely to refrain from tanning during the study.
• •Participation in a study of another device or drug within three months prior to enrolment or during the study.
• •Significant concurrent illness (e.g. uncontrolled diabetes) or any disease state that in the opinion of the Investigator would interfere with the treatment or healing process
• •As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study.
• •Subjects who are opposed to possible damage to the hair follicles with possible loss of hair in the treatment area.
• •Received the following treatments in the area of the face to be treated during or within the noted timeframes prior to the study treatment:
• •1. Dermabrasion or chemical peel treatment within 3 months.
• •2. Any devices and/or Botox treatment within 6 months.
• •3. Collagen/fat injections or other methods of augmentation with injected or implanted material in the treated area within 9 months.
• •4. Resurfacing procedure, face lift or eyelid surgery within a year.
• •5. Having a permanent implant in the facial skin area, such as an injected chemical substance.
• •6. Any other surgery in treated area within 9 months of initial treatment or during the course of the study
• •7. Use of retinoids, antioxidants or therapeutic skin nourishing supplements at medicinal concentration within 2 months and oral retinoids within 6 months of the study