Single-Blind, Investigational Device Exemption Paired-Design, Non-Inferiority Trial With Confirmation for the Assessment of the Efficacy and Safety of a Universal Electrosurgical Device for Temporary Improvement of Mild and Moderate Wrinkles Around Both Eye Corners and Both Cheek Folds

Primary outcomes

1. CROW'S FEET GRADING SCALE (CFGS)

   Time frame: 16weeks

   CROW'S FEET GRADING SCALE (CFGS) To assess wrinkle improvement in each area around the eyes, the CFGS will be administered at baseline, at Week 4, and at Week 16. At baseline, the CFGS will be administered prior to application of the investigational device. Each wrinkle scale will be assessed by the investigator and an independent evaluator, who will use photographs of the area where the investigational device was applied taken at each time point, excluding screening. In the case of evaluation by the examiner, photographs are not used and evaluation is made through direct observation during the examination. The resting (neutral expression) CROW'S FEET GRADING SCALE (CFGS) score according to the degree of wrinkles is composed of 0 points (Absent : no wrinkles), 1 point (Mild : very fine wrinkles), 2 points (Moderate : fine wrinkles), 3 points (Severe : moderate wrinkles), and 4 points (Extreme : severe wrinkles), with a lower score indicating the absence of wrinkles.

2. CHEEK Line GRADING SCALE (CLGS)

   Time frame: 16weeks

   The Cheek Line Grading Scale (CLGS) will be administered at screening, baseline, weeks 4, and 16 to assess wrinkle improvement in each cheek area. The baseline assessment will be conducted prior to application of the clinical trial device. Each wrinkle scale will be assessed by the investigator and an independent evaluator, who will use photographs of the clinical trial device application site taken at each time point, excluding screening. In the case of evaluation by the examiner, photographs are not used, and evaluation is made through direct observation during the examination. The Cheek Line Grading Scale (CLGS) according to wrinkle severity is composed of 0 points (no wrinkles), 1 point (Minimal : 1~2 superficial lines), 2 points (Moderate : 3~5 superficial lines), 3 points (Severe : Greater than 5 superficial lines; no crosshatching), 4 points (Diffuse : Diffuse superficial lines; crosshatching), with a lower score indicating an absence of wrinkles.