Secret Micro-Needle Fractional RF System® for the Treatment of Facial Wrinkles

Exclusion Criteria

• •1. A subject who has undergone treatment with any non-ablative laser, including IPL, within the last 3 months and any ablative laser within the last 6 months.
• •2. A subject who has undergone any microneedling treatment within the last 3 months
• •3. A subject with a history of previous fat transfer, injectable calcium hydroxylapatite or poly-l-lactic acid to the study area within the past 6 months.
• •4. A subject with a history of injection of hyaluronic acid dermal fillers in the study area within the past six months.
• •5. Retinoid, hydroquinone, microdermabrasion, or chemical peel treatments to the face within one month prior to study participation or during the study.
• •6. Current participation or participation within 30 days prior to the start of this study in a drug or other investigational research studies.
• •7. Presence of an active systemic or local skin disease that may affect wound healing.
• •8. Presence of scarring, sunburn, tattoos, open wounds or other skin condition in area to be treated that would interfere with the assessments of this study.
• •9. Individuals who have current skin cancers or suspicious lesions in the treatment area per Investigator.
• •10. Individuals who are nursing, pregnant, or planning to become pregnant during the study.
• •11. Patients who have a history with keloid formation or hypertrophic scarring.
• •12. Inability to understand the protocol or to give informed consent.
• •13. Subjects with deep dermal scarring or thick sebaceous skin of the treatment area.
• •14. History of impaired immune system, including but not limited to HIV, current malignancy.
• •15. History of chronic drug or alcohol abuse.
• •16. Current smoker or history of smoking in the last one year.
• •17. Subjects with known bleeding disorder or is receiving medication that will likely increase the risk of bleeding as the result of injection per investigator discretion.
• •18. Concurrent therapy that, in the investigator's opinion, would interfere with the evaluation of the safety or efficacy of the study device.
• •19. Subjects who anticipate the need for surgery or overnight hospitalization during the study.
• •20. Subjects who, in the investigator's opinion, have a history of poor cooperation, noncompliance with medical treatment, or unreliability.
• •21. History of using the following prescription medications:
• •1. Current use of psychiatric drugs that in the investigators opinion would impair the subject from understanding the protocol requirements or understanding and signing the informed consent.
• •2. Immunosuppressive medications.
• •22. Subjects with implantable cardiac devices, such as pacemakers or implantable cardioverter-defibrillators.