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9
5 Benefits
The device is indicated for the permanent reduction of unwanted hair.
A clinical trial was performed to assess both the safety and efficacy of the device. 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 one 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 device;
• Each subject received 12 weekly treatments to their chosen body location. A typical treatment consisted
of shaving the site then applying the device following the same process as outlined in Section 7, 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 counted via high resolution
photography and the difference in hair counts was calculated as a percentage change;
• When used as directed, the clinical trial participants showed on average 44% less hair 6 months after
their last treatment and 36% less hair 12 months after their last treatment when compared to hair counts
taken before treatment (see table below). Actual results did vary from person to person.
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 device to their friends.
6 Intended Use of Silk·expert
USE
The device is intended for the permanent reduction in unwanted, visible hair for a single user.
BODY AREAS
Women: Legs, arms, underarms, bikini area and face (below the cheek bones)
CAUTION: Do not use the device near the eyes, along the forehead, on the lips or
nostrils. Do not use it in the genital area.
Men: Shoulders and below (chest, back, arms, stomach, legs)
CAUTION: Do not use on the face, neck or genital area.
The device is intended to be used on body hair below the neck, including arms,
underarms, bikini line, stomach and legs.
SKIN COLOR
The device is intended for use on light, medium and dark skin tones up to and including skin tone V (see
Skin tone chart on page 3). The device incorporates two Skin Tone Sensors that measure the color of your
skin and will prevent use if your skin tone is too dark.
HAIR COLOR
The device is intended for use on naturally black or brown hair. It may not be as effective on white, grey,
blonde or red hair.
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CSS APPROVED Effective Date 18Oct2016 GMT - Printed 04Jan2017 Page 9 of 18
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