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

Inclusion criteria

• Healthy, male or female subjects over 21 years of age who are seeking treatment and reduction of their acne scarring.
• Able to read, understand and voluntarily provide written Informed Consent.
• Able and willing to comply with the treatment/follow-up schedule and requirements.
• Women of child-bearing age are required to be using a reliable method of birth control at least 3 months prior to study enrollment and for the duration of the study and have a negative Urine Pregnancy test at baseline.

Exclusion criteria

• Implantable defibrillators, cardiac pacemakers, and other metal implants
• Subjects with any implantable metal device in the treatment area
• Pacemaker or internal defibrillator, or any other active electrical implant anywhere in the body (e.g. cochlear implant).
• Permanent implant in the treated area, such as metal plates and screws, or an injected chemical substance.
• Current or history of any kind of cancer, or pre-malignant moles.
• Severe concurrent conditions, such as cardiac disorders.
• Pregnancy or intending to become pregnant during the study and nursing.
• Impaired immune system due to immunosuppressive diseases, such as AIDS and HIV, or use of immunosuppressive medications.
• 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.
• Poorly controlled endocrine disorders, such as diabetes.
• Any active condition in the treatment area, such as sores, psoriasis, eczema, and rash.
• History of skin disorders, such as keloids, abnormal wound healing, as well as very dry and fragile skin.
• History of bleeding coagulopathies, or use of anticoagulants (excluding daily aspirin).
• Facial dermabrasion, facial resurfacing, or deep chemical peeling within the last three months, if face is treated.
• 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.
• Use of non-steroidal anti-inflammatory drugs (NSAIDS, e.g. ibuprofen containing agents) one week before and after each treatment session.
• Any surgical procedure in the treatment area within the last six months or before complete healing.
• Treating over tattoo or permanent makeup.
• Excessively tanned skin from sun, tanning beds or tanning creams within the last two weeks.
• As per the practitioner's discretion, refrain from treating any condition which might make it unsafe for the patient.