Safety and Efficacy of a 2,910 nm Fractional Ablative Fiber Laser (UltraClear®) for Improvements of Skin Laxity and Lifting of the Lower Face, Submental, and Neck Treatment Areas
FA Corporation
Summary
This study evaluates the safety and effectiveness of the UltraClear® 2,910 nm fractional ablative fiber laser for improving skin laxity and tissue lifting in the lower face, submental, and neck areas. Up to 50 adults ages 35-65 will receive two laser treatments approximately 7 weeks apart at two clinical sites. Outcomes will be assessed approximately 90 days after the second treatment using photographic analysis and investigator- and participant-reported improvement scales.
Eligibility
- Age range
- 35–65 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: 1. Fitzpatrick skin types I-III participants with Fitzpatrick Skin Types IV-VI may be enrolled only at the investigator's discretion, based on individualized risk assessment documenting skin tone-related risk of post-inflammatory hyperpigmentation, wound healing history, and prior response to ablative or energy-based treatments. Risk assessment documentation must be retained in the participant's study file. Male or female. 2. Participants must be between 35 and 65 years of age. 3. Participants must have the ability to receive two lower face and full neck resurfacing laser…
Interventions
- Device2910 nm fiber laser (UltraClear®)
UltraClear® is a 2,910 nm fractional ablative erbium-doped fluoride glass fiber laser (Acclaro), FDA 510(k) cleared (K210847, K233803) for dermatological procedures requiring coagulation, resurfacing, and ablation of soft tissue. In this study, it is applied to the lower face, submental region, and neck using fractional ablative resurfacing, laser-coring, and full ablative resurfacing configurations, with mode and parameters selected by the investigator based on baseline anatomy and tissue laxity.
Locations (2)
- Julene B Samuels MD, FACSProspect, Kentucky
- Dermatology & Laser Surgery CenterHouston, Texas