Evaluation of Safety and Efficacy of TriPollar Device for Treatment of Wrinkles

Evaluation of Safety and Efficacy of TriPollar Device for Treatment of Wrinkles and Rhytides

The TriPollar is intended for non invasive treatment of facial wrinkles and rhytides. This study was designed in order to evaluate the safety and efficacy of the TriPollar.

The TriPollar technology is based on three or more electrodes designed to deliver RF current focused into the skin, thus generating heat in the dermal layer. Selective and focused electro-heating of the skin is intended to stimulate collagen remodeling in the dermal layer resulting in non invasive wrinkle treatment.

Inclusion Criteria:

• Subject read, discussed and signed the Consent Form,
• Healthy female/male aged 35 65 years,
• Has facial wrinkles,
• Capable of reading, understanding and following instructions of the procedure to be applied,
• Able and willing to comply with the treatment and follow-up schedule.

Exclusion Criteria:

• Listed in approved protocol, and ICF