Study of Radiofrequency Device for Use in Non-Invasive Cosmetic Procedures

Inclusion criteria

• Male or female 21 to 70 years old,
• For females, at least 9 months post-partum,
• Clinically appreciable skin laxity on the abdomen, thigh, upper arms or neck as determined by the study investigator,
• For females, post-menopausal, surgically sterilized, or using a medically accepted form of birth control for at least 3 months prior to the study,
• Apparently healthy,
• Informed consent signed by the subject.

Exclusion criteria

• History of skin hypersensitivity,
• Current skin disorder (e.g. keloid scarring) or infection (e.g., herpes simplex),
• Use of non-steroidal anti-inflammatory drugs within past 2 weeks,
• Suffering from hormonal imbalance which may affect weight or cellulite,
• Subjects with 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,
• Infectious diseases (such as HIV) present,
• Are a tobacco smoker,
• 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.