To assess the efficacy and safety of novel intelligent microfocused ultrasound (iMFU) in improving skin sagging.

Participants with facial sagging were enrolled and iMFU treatment was performed on the randomized middle and lower hemiface.

32 patients successfully completed the study. Quantitative analysis revealed obvious changes following iMFU treatment: the average length of perioral wrinkles and nasolabial folds on iMFU sides decreased by 7.2% (p < 0.001) and 18.5% (p = 0.011) in month-2 follow-up time. IMFU treatment also showed significant improvements in nasolabial fold angle (from 29.5 ± 4.3 to 30.7 ± 2.1) and area (37.5 ± 0.6 to 35.1 ± 1.2). Perioral folds achieved a similar therapeutic effect. Side face angle a demonstrated a significant increase from 12±2.6° to 13±1.5°, while the mandibular angle b similarly increased from 16±2.4° to 18±1.9° on iMFU sides.

IMFU treatment demonstrates both safety and efficacy for facial rejuvenation.