Trials / Completed
CompletedNCT04993066
Clinical Evaluation to Assess the Safety and Efficacy of GentleMax Pro Plus
Clinical Evaluation to Assess the Safety and Efficacy of GentleMax Pro/ GentleMax Pro Plus
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 77 (actual)
- Sponsor
- Candela Corporation · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
Demonstrate the safety and efficacy of the GentleMax Pro Plus™ laser system for its intended uses: hair removal including pseudofolliculitis barbae (PFB), clearance of pigmented and/or vascular lesions, temporary increase of clear nail in patients with onychomycosis and improvement in appearance of wrinkles. Evaluate GentleMax Pro Plus™ laser system for the clearance of acne.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | GentleMax Pro Plus | The GentleMax Pro Plus laser system to be used in this study received 510(k) market clearance from the U.S. Food and Drug Administration (FDA) under K201111 on May 26, 2020 |
Timeline
- Start date
- 2020-11-12
- Primary completion
- 2022-05-31
- Completion
- 2023-04-27
- First posted
- 2021-08-06
- Last updated
- 2023-11-14
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04993066. Inclusion in this directory is not an endorsement.