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Lutronic Genius System for Neck Treatment

NCT03534609 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2020-01-13

No results posted yet for this study

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.

Conditions

  • Wrinkle
  • Skin Laxity
  • Skin Texture Disorder

Interventions

DEVICE

Lutronic Genius System

Treatment of the neck using the Lutronic Genius System

Sponsors & Collaborators

  • LUTRONIC Corporation

    lead INDUSTRY

Principal Investigators

  • Kari Larson, MBA · Sponsor GmbH

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-03-27
Primary Completion
2019-01-16
Completion
2020-01-10
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03534609 on ClinicalTrials.gov