Ulthera DeepSEE DS 10 -1.5, Instructions For Use Manual

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Ulthera, Inc.
2.5. Potential Side Effects
Side effects reported in the clinical evaluation of the Ulthera System for the
brow, submental (under the chin) area and neck treatment(s) were mild and
transient in nature. These were limited to:
• Erythema (redness): The treated area may exhibit erythema immediately
following treatment. This typically resolves within a few hours of treatment.
•
Edema (swelling): The treated area may exhibit mild edema following
treatment. This typically resolves within 3 to 72 hours of treatment.
•
Welting: The treated area may exhibit a localized area of linear visible
edema following treatment. This typically resolves within a week.
•
Pain: Momentary discomfort may be experienced during the procedure
while energy is being deposited. Post procedure discomfort typically
resolves within 2 hours and 2 day. Tenderness to the touch is also possible
and typically resolves within 2 days to 2 weeks of treatment.
•
Bruising: Mild bruising, which is caused by damage to soft tissue blood
vessels, may occur occasionally and typically resolves within 2 days to 2
weeks of treatment.
•
Nerve Effects:
o Transient local muscle weakness may result after treatment due to
inflammation of a motor nerve. This typically resolves in 2 to 6 weeks
of treatment.
o
Transient numbness may result after treatment due to inflammation
of a sensory nerve. This typically resolves in 2 to 6 weeks of
treatment.
o
Transient pain, paresthesia and/or tingling may be experienced.
This typically resolves in 2 to 6 weeks of treatment.
No permanent injuries to facial nerves were reported during clinical trials.
•
Burns/Scarring: The possibility for burns, which may or may not result in
permanent scar formation, may occur if incorrect treatment technique is
used (e.g. tilting transducer, incorrect line spacing, gel pockets, etc. see
section 7.3.4 & 7.3.5). Some scars may respond to medical treatment and
resolve fully.
Side effects reported in the clinical evaluation of the Ulthera System for the
décolleté treatment were mild and transient in nature. These were limited to:
•
Erythema (redness): The treated area may exhibit erythema immediately
following treatment. This typically resolves within a few hours of treatment.
• Edema (swelling): The treated area may exhibit mild edema following
treatment. This typically resolves within 3 to 48 hours of treatment.
•
Pain: Momentary discomfort may be experienced during the procedure
while energy is being deposited. Post procedure discomfort typically