NCT03534609

Lutronic Genius System for Neck Treatment

Exploratory Evaluation of the Lutronic Genius System for Treatment of the Neck

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: CynosureLutronic · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The Genius system is substantially equivalent to the Infini device (K121481). The study is a prospective, multi-site, non-randomized study of up to 30 treated subjects presenting for treatment of mild to moderate lines, wrinkles, textural concerns, and/or skin laxity of the neck.

Detailed description

At enrollment, standardized baseline/pretreatment 2D and 3D images will be obtained from each subject. Study subjects will receive three neck treatments completed 30 days apart. Subjects will be contacted via a phone call 3 days following each treatment to assess for adverse events and expected treatment effects. Effectiveness assessments will occur prior to Treatments #2 and #3, and a follow-up visit will be completed at 90 days following Treatment #3. Each assessment visit will include efficacy, adverse events, and expected treatment effects assessments, and post-treatment 2D and 3D digital images will be captured.

Conditions

• Wrinkle
• Skin Laxity
• Skin Texture Disorder

Interventions

Type	Name	Description
DEVICE	Lutronic Genius System	Treatment of the neck using the Lutronic Genius System

Timeline

• Start date: 2018-03-27
• Primary completion: 2019-01-16
• Completion: 2020-01-10
• First posted: 2018-05-23
• Last updated: 2020-01-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study