Investigation of Radiofrequency Device for Treatment of Wrinkles and Rhytides

Exclusion Criteria

• •Tobacco smokers,
• •History of skin hypersensitivity,
• •Current skin disorder or infection (e.g., herpes simplex),
• •Prior cosmetic treatments to the face (e.g. Botox) or facial fillers (e.g. Restylane),
• •Subjects with a pacemakers, internal defibrillators or electronically, magnetically, and mechanically activated implants,
• •Subjects with implanted medical prostheses (such as clips, pins or plates) proximal to the treatment site,
• •The current or recent use (within the past 12 months) of isotretinoin,
• •Pregnancy or breast feeding,
• •Insulin dependent diabetic subjects,
• •Oxygen dependent subjects,
• •Subjects with severe chronic illness, scleroderma, or lupus,
• •Subjects with open sores or scars in the treatment region, or
• •Subjects with ischemia in the treatment region.