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Smoothskin Pure Mini Lite Manual De Instrucciones página 18

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5. BENEFITS OF USING SMOOTHSKIN PURE
MINI LITE
The SmoothSkin Pure Mini Lite is indicated for the permanent reduction of unwanted hair.
A clinical trial was performed to assess both the safety and efficacy of the SmoothSkin
Pure Mini Lite. The key features of the clinical trial were:
All treatments were performed by non-medically trained operators at a single location using
devices identical to the SmoothSkin Pure Mini Lite provided in this package;
All subjects were required to complete questionnaires related to their general health and
those who could not be treated, e.g. those who had one or more of the contraindications as
listed in Section 3 of this User Manual were excluded. In addition, all subjects were required
to provide Informed Consent as per international clinical trial requirements;
A total of 53 female subjects, aged between 19 and 45 years old, commenced the trial;
Three subjects left the trial during the treatment period for personal reasons. No subjects
left the trial due to problems associated with the use of the SmoothSkin Pure Mini Lite;
Each subject received 12 weekly treatments to their chosen body location. A typical
treatment consisted of shaving the site then applying the SmoothSkin Pure Mini Lite
following the same process as outlined in Section 8, Step 3 of this user manual;
Hair counts were used to measure the change in the amount of hair 6 months after the
last treatment and 12 months after the last treatment. The hairs in the treatment sites were
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