Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hair removal | Experimental | hair removal treatment using 805nm LightSheer Duet HS handpiece |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LightSheer Duet HS handpiece | Device | The approach to be studied here relies on a cleared modality, the LightSheer Duet High Speed (HS) that uses 805 nm diode laser with vacuum (K053628). |
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with Adverse Events | To evaluate the safety of hair removal using the LightSheer Duet HS 805 nm handpiece | 1 year |
| Hair count | To verify hair removal and permanent hair reduction using the LightSheer Duet HS 805 nm handpiece | 6 monts follow up |
| Measure | Description | Time Frame |
|---|---|---|
| Subject's comfort using VAS | To evaluate subject's assessment of comfort associated with treatments | Baseline, 4, 8, 12, 16 weeks; |
| Asses subject's perception of improvement and satisfaction | To evaluate subject's satisfaction with hair removal treatments and assessment of improvement using subject's questionnaire |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Suzanne Kilmer, MD | Laser & Skin Surgery Medical Group, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Laser & Skin Surgery Medical Group Inc | Sacramento | California | 95816 | United States |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Jan 25, 2017 | |
| Reset | Mar 14, 2017 |
Not provided
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jan 25, 2017 | Mar 14, 2017 |
Not provided
Not provided
Not provided
Not provided
Not provided
| 8, 16 weeks following baseline; 3 and 6 monts follow up |