Renuvion Dermal System for Dermal Resurfacing

Exclusion Criteria

• •1. Subject with a Fitzpatrick Skin Scale score ≥IV.
• •2. Subject is pregnant or lactating.
• •3. Active HSV-1 or diabetes mellitus.
• •4. Active cut, wound, or infection on the skin of the face.
• •5. Subject has used, within 30 days prior to screening or plans to use during study participation, Accutane, Retinol, or any medication that can cause dermal hypersensitivity.
• •6. Subject has used, within 10 days prior to study treatment, aspirin or NSAIDs.
• •7. Subject has a history of autoimmune disease (excluding Hashimoto's thyroiditis).
• •8. Subject with a known bleeding disorder or who is on blood thinning medication that may be at risk for bleeding.
• •9. Subject has a known adverse reaction to lidocaine and/or epinephrine.
• •10. Subjects with active skin disease of the facial area or known connective tissue disease.
• •11. Subjects with known susceptibility to keloid formation or hypertrophic scarring.
• •12. Subjects with present cancerous or pre-cancerous lesions in the area to be treated.
• •13. Subject who, for any reason, suspects that they will not be able to complete the prescribed follow-up assessment(s).
• •14. Subject has had concurrent therapy that, in the investigator's opinion, would interfere with the evaluation of the safety and effectiveness of the study treatment method.
• •15. Subject is not willing to release rights to study Sponsor for the use of the photos, including in potential publication.
• •16. Subject is enrolled in another investigational (drug or device) clinical trial that can interfere with this study's assessments.
• •17. Subject has undergone a facelift procedure within 12 months prior to the screening visit.
• •18. Subject has received IPL, microneedling, or chemical peels within 3 months prior to the screening visit.
• •19. Subject has received microneedling with RF or any facial treatment with an energy-based device within 6 months prior to the screening visit.
• •20. Subject has received facial injections with BOTOX® or other toxins within 6 months prior to the screening visit.
• •21. Subject has received hyaluronic acid or calcium hydroxylapatite fillers within 4 months prior to the screening visit.
• •22. Subject who is a family member or employee of the investigator or sponsor.
• •23. Participation in any other investigational study within 30 days prior to consent.
• •24. Subject who, in the opinion of the investigator, is not an appropriate candidate for the study.