Treatment to Lift Facial Lax Skin and Improve Facial Wrinkles Using Precise and Lift Applicators

Eligible patients will receive 1-2 face and/or neck and/or submental treatments (per PI discretion, 2-12 weeks apart) using the SofWave system with the Lift or/and Precise applicators.

Treatment may be administered after the enrollment and screening at the first visit, or it may occur at a later date following the enrollment and screening activities based on site scheduling availabilities.

All patients will return to the clinic for one follow-up visit at 3 months ± 2 weeks post last treatment (FU1).

Methodology described in the protocol to evaluate efficacy and safety of treatments will be carried out at each visit at the clinic.

Inclusion criteria

• Healthy female and male subjects between the ages 35-80.
• Non-Smoker.
• Fitzpatrick skin type I-VI.
• Desire to lift facial lax skin, neck and/or submental and/or to lift the eyebrow area and/or improve facial wrinkles appearance.
• 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.

Exclusion criteria

• 1. 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.

• Presence of active local skin disease that may alter wound healing.

• Severe solar elastosis.

• Currently a smoker or has a history of heavy smoking (25 cigarettes per day or more) 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.

• Severe or cystic facial acne, and/or Accutane use during past 6 months.

• 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 facial area to be treated, including facial skin-tightening procedure within the past 6 months; injectable (Botox or fillers) of any type within the past 6 months; ablative or non-ablative resurfacing/rejuvenation laser treatment or light treatment within the past 6 months, dermabrasion or deep facial peels within the past 12 months; facelift, blepharoplasty, or brow lift (including contour threads) within the past 12 months.

• Taking Isotretinoin or other oral retinoid within the past 6 months; taking anti-platelet or anti-coagulant 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.