Lax Skin Clinical Trial
Official title:
Safety and Efficacy of SofWave Treatment to Lift Facial Lax Skin and Improve Facial Wrinkles Using Precise and Lift Applicators
Open-label, non-randomized single-arm prospective, multi-center, self-controlled clinical study with masked evaluation.
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. ;
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