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POTENTIAL
ADVERSE EVENT
Use on or by anyone
under the age of 18.
Use by a pregnant
woman.
Failure to stop
use of the Tria
SmoothBeauty™ Laser
on skin that
is darkening.
12
POTENTIAL
ADVERSE EFFECT
If not used properly
could result in
serious injury.
Safety risks to
pregnant women
are unknown.
Temporary
skin darkening
LIKELIHOOD OF POTENTIAL
ADVERSE EFFECT
Very unlikely. Not reported in the
clinical study.
Unlikely. Not reported in the
clinical study.
Unlikely with normal use.
In the clinical study, 16 out of 60
participants (27%) experienced
temporary skin darkening, 5 of
which experienced skin darkening
lasting longer than 3 months.
Users with darker skin tones are
more prone to persistent redness
that can result in skin darkening.
If persistent redness occurs,
discontinue use until it resolves.
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