* The study will re-confirm that the LightSheer Duet HS 805 nm handpiece is safe for removal of unwanted hair, and will result in hair removal and permanent hair count reduction. * Twenty (20)subjects, Fitzpatrick Skin Type I-IV will be included in a single site. * Each subject will receive five treatments at four to six week intervals and return for follow-up visits at three and six months after the last treatment for evaluation of the treated areas.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
21
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).
Laser & Skin Surgery Medical Group Inc
Sacramento, California, United States
Number of subjects with Adverse Events
To evaluate the safety of hair removal using the LightSheer Duet HS 805 nm handpiece
Time frame: 1 year
Hair count
To verify hair removal and permanent hair reduction using the LightSheer Duet HS 805 nm handpiece
Time frame: 6 monts follow up
Subject's comfort using VAS
To evaluate subject's assessment of comfort associated with treatments
Time frame: 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
Time frame: 8, 16 weeks following baseline; 3 and 6 monts follow up
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