Tria SRL - Page 7

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POTENTIAL
ADVERSE EVENT
POTENTIAL
ADVERSE EFFECT
LIKELIHOOD OF POTENTIAL
ADVERSE EFFECT
Use of the Tria
Age-Defying Laser
on skin that is
infected, burned
or cut.
Discomfort or
irritation.
Unlikely. Not reported in the
clinical study.
Use of the Tria
Age-Defying Laser
to treat your eye,
or eyelids or aiming
the Tria Age-Defying
Laser directly into
your eyes.
Serious eye injury
such as a permanent
or temporary decrease
in vision or permanent
blindness.
Very unlikely. Not reported in the
clinical study.
Use of the Tria
Age-Defying Laser
on tattooed skin.
Damaged tattoo
or increased risk
of skin injury.
Very unlikely. Not reported in the
clinical study.
If the device is used improperly or it malfunctions, there are other risks. The following chart
lists some of these risks:
POTENTIAL
ADVERSE EVENT
POTENTIAL
ADVERSE EFFECT
LIKELIHOOD OF POTENTIAL
ADVERSE EFFECT
Treating each zone
more than once per
day (once every
24 hours).
Increased risk of
skin irritation.
Very unlikely with normal use.
The Tria Age-Defying Laser was
used only once per day in the
clinical study with participants
experiencing only minor skin
irritation, such as:
•Redness:57outof60
participants (95%)
•Stinging:55outof60
participants (92%)
•Burningsensation:50outof60
participants (83%)
•Warmth:47outof60
participants (78%)
More noticeable skin irritation may
result if treating each zone more
than once per day.