Clinical Study to Determine Safety and Efficacy of FPlus for Wrinkle Treatment

Inclusion criteria

• Subjects with mild to moderate facial wrinkles and rhytides .
• Males and females 21 - 65 years of age.
• Willingness to follow the treatment schedule, and have photographs taken.

Exclusion criteria

• Pacemaker or internal defibrillator, or other implanted metallic or electronic device.
• Permanent implant in the treated area such as metal plates and screws or silicon, unless deep enough in the periosteal plane.
• Avoid treatment if intra-dermal or superficial sub-dermal areas have been injected with Botox/HA/collagen/fat injections or other augmentation methods with bio-material during last 6 months.
• Current or history of skin cancer, or any other type of cancer, or pre-malignant moles.
• Severe concurrent conditions, such as cardiac disorders.
• Pregnancy or nursing.
• Impaired immune system due to immunosuppressive diseases such as AIDS and HIV, or use of immunosuppressive medications.
• Patients with history of diseases stimulated by heat, such as recurrent Herpes Simplex in the treatment area, may be treated only following a prophylactic regime.
• Poorly controlled endocrine disorders, such as diabetes.
• Any active skin condition in the treatment area, such as sores, psoriasis, eczema, and rash.
• History of skin disorders, keloids, abnormal wound healing, as well as very dry and fragile skin.
• History of bleeding coagulopathies, or use of anticoagulants in the last 10 days.
• Any facial surgery performed within 12 months prior to treatment.
• Facial dermabrasion, facial resurfacing, or deep chemical peeling within the last 3 months.
• Having received treatment with light, laser, RF, or other devices in the treated area within 6 months.
• Use of Isotretinoin (Accutane®) within 6 months prior to treatment.
• Treating over tattoo or permanent makeup.
• As per the practitioner's discretion, refrain from treating any condition that might make it unsafe for the patient.