Safety and Efficacy of Sofwave Treatment for Acne Scars Appearance Improvement

Exclusion Criteria

• •1. Pregnant or planning to become pregnant during the duration of the study, having given birth less than 3 months ago, and/or breast feeding
• •2. Current smoker or has history of heavy smoking (25 cigarettes per day or more) in past 10 years.
• •3. History of severe migraine tendency.
• •4. History of Epileptic seizures.
• •5. History of chronic drug or alcohol abuse.
• •6. Taking Isotretinoin or other oral retinoid within the past 6 months; taking anti-platelet or anti-coagulant within the past 2 weeks.
• •7. Medical disorder that may hinder the wound healing or immune response (such as blood disorder, inflammatory disease, etc.)
• •8. Presence of a metal stent or implant in the facial area.
• •9. Known allergy to tetracaine, Xylocaine or epinephrine.
• •10. Active malignancy or history of malignancy in the past 5 years.
• •11. Suffering from significant concurrent illness, such as cardiac disorders, diabetes (type I or II), lupus, porphyria, or pertinent neurological disorders (i.e. any disease state that in the opinion of the investigator may interfere with the anesthesia, treatment, or healing process).
• •12. History of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or currently using immunosuppressive medications.
• •13. Presence of any active systemic or local infections.
• •14. Severe or cystic facial acne, acutance uses during past 6 months.
• •15. History of cosmetic treatments in the facial area to be treated, including facial skin-tightening procedure within the 6 months; injectable (Botox or fillers of any type) within the 6 months; ablative or non-ablative resurfacing/rejuvenation laser treatment or light treatment within the past 6 months, dermabrasion or deep facial peels within the past 12 months; facelift or blepharoplasty within the past 12 months.
• •16. Inability to understand the protocol or to give informed consent
• •17. On-going use of psychiatric medication
• •18. Unable or unwilling to comply with the study requirements and procedures
• •19. Currently enrolled in a clinical study of any other unapproved investigational drug or device
• •20. As per the investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study.