The Ultherapy® System should not be applied close to or directly over any of the following:
- Open wounds or sores
- Severe or cystic acne
- Implanted electronic devices, such as pacemakers, cochlear implants, electronic monitoring, or drug delivery devices
- Metallic implants, such as dental implants, fracture plates or rods
- Mechanical implants
- Dermal fillers
- Breast implants or breast tissue
- Keloid (raised scar tissue)
- Thyroid gland, thyroid cartilage and trachea
- Major vessels
The Ultherapy® System has not been evaluated for use in the following populations:
- Those on an anticoagulant (blood thinning) treatment plan
- Pregnant or breastfeeding women
- Children
The Ultherapy® System has not been evaluated for use in people with the following conditions:
- A haemorrhagic disorder or haemostatic dysfunction (such as haemophilia or Von Willebrand disease)
- An active systemic or local skin disease that may alter the skin’s ability to heal
- Herpes simplex (cold sores)
- Autoimmune disease
- Diabetes
- Epilepsy
- Bell’s palsy
