Safety and Efficacy Evaluation of the Monopolar Radiofrequency Device for the Improvement of Facial Wrinkles

Exclusion Criteria

• •1. Individuals with skin diseases, scars, open wounds, or metal implants in the area where clinical trial medical devices will be applied.
• •2. Patients with implanted electrical devices (e.g., pacemakers, AICDs).
• •3. Those with a history of hypertrophic scars, keloids, or severe allergic reactions.
• •4. Individuals with excessive facial fat requiring surgical treatment.
• •5. Those with autoimmune diseases, acute viral herpes, or poorly controlled diabetes.
• •6. People with abnormal coagulation function or those taking anticoagulant medications (e.g., aspirin, warfarin) within 1 week of screening.
• •7. Individuals treated with fillers or botulinum toxin within the last 6 months or permanent fillers in the treatment area.
• •8. Those who have received skin treatments (e.g., deep exfoliation, lasers, light therapy) in the treatment area within 6 months.
• •9. Pregnant or lactating women, or women of childbearing potential not using medically accepted contraception.
• •10. Persons deemed inappropriate by the investigator to participate in this clinical trial.