Benefits Of Using Smoothskin Pure Fit - Smoothskin PURE FIT Manual Del Usuario

SIDE EFFECT
Skin redness which does not disappear within minutes
and lasts 24-48 hours.
Pain or discomfort that is intense during treatment or
persists after a treatment.
IN VERY RARE CASES
Swelling and redness that does not disappear within
two to three days.
Temporary changes in skin colour (lightening
or darkening).
Blistering, scarring or burning of the skin.
In a clinical trial of 50 subjects, each subject received 12 weekly treatments. The recorded effects were:
Itchiness – Four subjects experienced mild itchiness after treatment.
•
Slight Redness – This was reported by 1 subject.
•
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HOW TO ASSESS & REACT
Stop using the device immediately and consult your
physician before using it again.
Stop using the device immediately and consult your
physician before using it again.
HOW TO ASSESS AND REACT
Stop using the device immediately and consult your
physician before using it again.
If your skin colour changes, stop using the device
immediately and consult your physician.
Stop using the device immediately and consult your
physician before using it again. Apply a cold pack to the
area. Treat with antiseptic or burn cream.
Mild Stinging Sensation – Five subjects reported mild discomfort following treatment.
•
In-growing Hair – One subject reported experiencing an in-growing hair following treatment.
•
Follicle Redness – One subject reported a red spot at the treatment site following treatment.
•
In all cases, the treated skin returned to normal within 7 days.
5. BENEFITS OF USING SMOOTHSKIN PURE
SmoothSkin Pure Fit is indicated for the permanent reduction of unwanted hair.
A clinical trial was performed to assess both the safety and efficacy of SmoothSkin Pure Fit. 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 SmoothSkin Pure Fit 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;
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