Page 8 Ulthera, Inc.
2. Medical Safety
2.1. Indications for Use
The Ulthera System is indicated for use as a non-invasive dermatological
aesthetic treatment to:
• Lift the eyebrow
• Lift lax submental (beneath the chin) and neck tissue
• Improve lines and wrinkles of the décolleté
The Ulthera System, in conjunction with the Ulthera DeepSEE transducer,
allows for ultrasonic visualization of depths up to 8 mm below the surface of
the skin. The indicated use of the imaging is to visualize the dermal and
subdermal layers of tissue to:
• Ensure proper coupling of the transducer to the skin
• Confirm appropriate depth of treatment such as to avoid bone
2.2. Contraindications
The Ulthera System is contraindicated for use in patients with:
• Open wounds or lesions in the treatment area
• Severe or cystic acne in the treatment area
• Act iv e implants (e.g., pacemakers or defibrillators), or metallic implants in
the treatment area
2.3. Precautions
When not in use by trained personnel, the Ulthera System Access Key should
be removed from the system to help prevent unauthorized use. Keep the
Ulthera System Access Key in a designated place accessible only to
authorized and trained personnel.
The Ulthera System has not been evaluated for use over various materials.
Therefore, treatment is not recommended directly over those areas with any
of the following:
• Mechanical implants
• Dermal fillers
• Breast implants
Treatment energy is not recommended for use directly on an existing keloid.
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