Safety and Effectiveness Evaluation of the High-intensity Focused Ultrasound Device for Lifting Lax Submental and Neck Tissue

Inclusion Criteria

• Male or female subjects aged 30 to 65 years, inclusive, at the time of informed consent.
• Subjects presenting with mild to moderate submental and/or neck skin laxity, as determined by the investigator.
• Subjects in good general health with stable body weight (±5%) for at least 6 months prior to screening.
• Subjects willing to avoid other aesthetic or dermatologic procedures (surgical or non-surgical) to the treatment area during the study period.
• Subjects able to understand and sign informed consent and comply with all study visits and procedures.
• Female subjects of child-bearing potential who agree to use reliable contraception throughout study participation.

Exclusion Criteria

• Prior facelift, neck lift, liposuction, or contouring surgery involving the lower face, submental, or neck areas.
• Receipt of any energy-based aesthetic treatment (e.g., HIFU, radiofrequency, laser) or injectable aesthetic treatment (e.g., botulinum toxin, dermal filler, collagen stimulator) to the treatment area within 6 months prior to baseline.
• Presence of any implanted electronic medical device, such as a pacemaker, defibrillator, or neurostimulator.
• Active skin infection, wound, cystic acne, inflammation, or severe scarring within or near the treatment area.
• History of keloid formation or abnormal wound healing.
• Known bleeding disorder, or use of anticoagulant or antiplatelet medications that cannot be safely discontinued for the procedure.
• Pregnant or breastfeeding women.
• Subjects with a known sensitivity or contraindication to ultrasound-based procedures.
• Any medical or psychiatric condition that, in the investigator's judgment, could interfere with study participation, safety, or data integrity.
• Participation in another investigational study within 30 days prior to screening.