Sofwave Medical LTD
Non-randomized single-arm prospective clinical study.
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: 1. Healthy female and male subjects between the ages 40-55. 2. Non-Smoker. 3. Fitzpatrick skin type I-VI. 4. Desire to lift facial lax skin, neck and/or submental and/or improve facial wrinkles appearance. 5. Presence of mild to moderate laxity in the lower face and submental area. 6. Able and willing to comply with all visits, treatments and evaluation schedules and requirements. 7. Able to understand and provide written Informed Consent. 8. Women of child-bearing age are required to be using a reliable method of birth control at least 3 months prior to study enrollment.…
The Sofwave System, comprised of an applicator and a console, generates high intensity, non-focused ultrasonic energy which can be delivered percutaneously to tissues
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