Tria SMOOTHBEAUTY LASER Instructions D'utilisation page 11

subjects) and warmth sensation (47 of 60
subjects). Clinical results show that these
side effects usually resolved within several
minutes or hours after a treatment. When
using the device daily, these side effects
may diminish and resolve before your next
daily treatment, however, depending on
how your skin responds to treatment, some
may not fully resolve before your next
daily treatment. Do not perform another
treatment until all side effects have fully
resolved. In the clinical study, all of these
side effects resolved within 4 weeks after
stopping treatment.
Other side effects reported in the clinical
study included: dry skin (21 of 60 subjects),
temporary skin darkening (16 of 60 subjects),
acne flare (14 of 60 subjects), headache
(4 of 60 subjects), temporary small brown
dots (8 of 60 subjects), skin sensitivity (9
of 60 subjects), macule (6 of 60 subjects),
skin roughness (3 of 60 subjects), skin
tenderness (3 of 60 subjects), skin peeling
(2 of 60 subjects), and cold sore flare
(2 of 60 subjects). Other side effects that
were each reported in one subject included
dry lips, ecchymosis, excoriation, and
venodilation. Not all of these side effects
may have been caused by the device.
Skin darkening that lasted more than
3 months after treatment was reported
in 5 of 60 subjects. If you experience skin
darkening, you should discontinue use of
the device.
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