20
21
SmoothSkin Bare+
Number of Subjects at 6 Months Post Treatment
50
Hair Reduction at 6 Months Post Treatment
43.9%
Number of Subjects at 12 Months Post Treatment
33
Hair Reduction at 12 Months Post Treatment
36.0%
% of Subjects met success (>30% hair reduction) on
all body areas at 12 months post-treatment. Subject
Success is defined as greater than 30% hair reduction at
all treatment sites at 12 months.
66.7%
•
The incidence of side effects during the clinical trial was minimal (as outlined in Section 4
above) and the majority of subjects (48 out of 50) would recommend the SmoothSkin Bare+
to their friends.
6. WHAT IS THE INTENDED USE OF THE SMOOTHSKIN BARE+
INTENDED USE
The SmoothSkin Bare+ is indicated for the removal of unwanted hair. The SmoothSkin Bare+ is also indicated for the permanent reduction in
hair regrowth, defined as the long-term, stable reduction in the number of hairs re-growing when measured at 6, 9 and 12 months after the
completion of a treatment regime.
7. YOUR SUITABILITY
BODY AREAS
SmoothSkin Bare+ is suitable for use on body hair and female facial hair below the
cheekline.
SKIN COLOUR
The SmoothSkin Bare+ is suitable for use on light, medium and dark skin tones up to
and including skin tone 5. The SmoothSkin Bare+ incorporates a Skin Tone Sensor that
measures the colour of your skin and will prevent use if your skin tone is too dark.
HAIR COLOUR
The SmoothSkin Bare+ is suitable for use on naturally black or brown hair. It may not be as effective on white, grey, blonde or red hair.
8. HOW TO USE THE SMOOTHSKIN BARE+
WARNING:
Follow each step in the treatment process ensuring you complete all aspects of each step before progressing to the next.
Step 1:
PREPARE the area to be treated
Remove all visible hair by shaving. Make sure there is no hair remaining above the
surface of the skin to ensure optimal treatment and prevent debris from covering the front
of the SmoothSkin Bare+.
