Evaluation of SofWave Sofware-Guided Energy Delivery for Lower Face and Neck Rejuvenation

Eligible subjects will receive 1 or 2 SofWave treatments (4-6 weeks apart) using the Total Treatment Energy (TTE) methods and will return to 3 follow up visits: at 4 weeks ± 2 weeks post last treatment (FU1), at 12 weeks ± 2 weeks post last treatment (FU2) , at 24 weeks ± 4 weeks post last treatment (FU3).

Inclusion criteria

• Healthy female and male subjects between the ages 40-55.
• Non-Smoker.
• Fitzpatrick skin type I-VI.
• Desire to lift facial lax skin, neck and/or submental and/or improve facial wrinkles appearance.
• Presence of mild to moderate laxity in the lower face and submental area.
• Able and willing to comply with all visits, treatments and evaluation schedules and requirements.
• Able to understand and provide written Informed Consent.
• Women of child-bearing age are required to be using a reliable method of birth control at least 3 months prior to study enrollment.
• Subject agrees not to undergo any other facial cosmetic treatment for a period of 3 months following last SofWave treatment.
• Stable weight over the last 12 weeks and throughout the duration of the study.
• Subjects agree to adhere to safe sun practices and daily use of broad-spectrum sunscreen SPF 30+.
• Male subjects with facial hair in the treatment area are willing to trim or shave as needed to allow consistent standardized photography.

-

Exclusion criteria

• Pregnant or planning to become pregnant, having given birth less than 3 months ago, and/or breast feeding.
• Presence of any active systemic or local infections.
• Open wounds or lesions within the intended to treat area.
• Tattoo or former tattoo at or near treatment area.
• Presence of active local skin disease that may alter wound healing.
• Uncontrolled diabetes mellitus.
• Skin cancer in the area to be treated. History of any other non-melanoma skin cancers in the past 5 years within the treatment area (head and neck).
• Severe solar elastosis.
• History of smoking in the past 10 years.
• History of chronic drug or alcohol abuse.
• Excessive subcutaneous fat on the cheeks.
• Significant scarring in the area to be treated or history of keloids.
• Severe or cystic facial acne, and/or Accutane use during the past 6 months.
• Pacemakers and electronic device implants in the treated area.
• Presence of a metal stent or implant in the facial area (dental implants and/or braces are not excluded).
• Inability to understand the protocol or to provide a signed informed consent.
• History of cosmetic treatments in the area to be treated including:

• Chemical peels, microneedling, dermabrasion, energy-based devices, or laser treatments in the past 6 months
• Injectable filler treatments in the past 6 months
• Injectable neuromodulator treatment in the past 4 months
• Cosmetic surgical procedures in the treatment area, including but not limited to facelift in the past 12 months.
• Taking anti-platelet or anti-coagulant within the past 2 weeks.
• Ongoing use of psychiatric medication; taking psychiatric drugs within the past 2 weeks.
• As per the investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study.

-