In Vivo Study to Evaluate Tissue Remodeling Via Fibroblast Stimulation Following a Single SofWave Treatment

Eligible subjects will arrive for a screening visit, and if will be found eligible and will provide signed ICF, during this visit a biopsy will be taken from the pre-auricular area.

At the second visit, a week after the screening visit, sutures from the biopsy (if present) will be removed, and subjects will receive a single treatment on the full face, neck, and submental area using the SofWave system with the Lift applicator.

Subjects will return to the clinic for a follow-up visit at one of the following timepoints (2 subjects per timepoint): 5 days, 4 weeks ± 2 days, 8 weeks ± 2 days, 12 weeks ± 4 days, or 24 weeks ± 4 days post-treatment. During this visit, an additional biopsy will be taken from the opposite pre-auricular side to that used at the screening visit.

All subjects will arrive for an additional visit, a week after the follow-up visit, for suture removal (if will exist).

Inclusion criteria

• Healthy female and male subjects between the ages 35-60
• 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.
• Willing to give biopsies.
• Able and willing to comply with all visits, treatments and evaluation schedules and requirements (including providing biopsies).
• 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

• 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.