Clinical Evaluation of the Safety and Performance of FRF for the Treatment and Reduction of Acne Scarring

Exclusion Criteria

• •1. Implantable defibrillators, cardiac pacemakers, and other metal implants
• •2. Subjects with any implantable metal device in the treatment area
• •3. Pacemaker or internal defibrillator, or any other active electrical implant anywhere in the body (e.g. cochlear implant).
• •4. Permanent implant in the treated area, such as metal plates and screws, or an injected chemical substance.
• •5. Current or history of any kind of cancer, or pre-malignant moles.
• •6. Severe concurrent conditions, such as cardiac disorders.
• •7. Pregnancy or intending to become pregnant during the study and nursing.
• •8. Impaired immune system due to immunosuppressive diseases, such as AIDS and HIV, or use of immunosuppressive medications.
• •9. History of diseases stimulated by heat, such as recurrent herpes simplex in the treatment area; may be enrolled only after a prophylactic regime has been followed for 2 weeks or longer prior to enrollment, or according to Investigator's discretion.
• •10. Poorly controlled endocrine disorders, such as diabetes.
• •11. Any active condition in the treatment area, such as sores, psoriasis, eczema, and rash.
• •12. History of skin disorders, such as keloids, abnormal wound healing, as well as very dry and fragile skin.
• •13. History of bleeding coagulopathies, or use of anticoagulants (excluding daily aspirin).
• •14. Facial dermabrasion, facial resurfacing, or deep chemical peeling within the last three months, if face is treated.
• •15. Use of isotretinoin (Accutane®) or other systemic retinoids within six months or topical retinoids within three months prior to treatment; or as per physician's discretion.
• •16. Use of non-steroidal anti-inflammatory drugs (NSAIDS, e.g. ibuprofen containing agents) one week before and after each treatment session.
• •17. Any surgical procedure in the treatment area within the last six months or before complete healing.
• •18. Treating over tattoo or permanent makeup.
• •19. Excessively tanned skin from sun, tanning beds or tanning creams within the last two weeks.
• •20. As per the practitioner's discretion, refrain from treating any condition which might make it unsafe for the patient.