Safety Information

The Ulthera® System is intended for lifting and sculpting of skin by way of the deposition of micro-focused ultrasound energy at depths between 1.5 mm and 4.5 mm beneath the skin. Deposition of ultrasound energy results in a change to the physiology, resulting in stimulation of new collagen and elastin as part of the healing process2.

 

The Ulthera System is also intended for the treatment of Axillary Hyperhidrosis by way of the deposition of the micro-focused ultrasound energy at depths between 3.0 mm and 4.5 mm beneath the skin, targeting the depth at which sweat glands reside. Coagulation takes place in tissue located at the dermal hypodermal interface where the sweat glands reside using a surface contact applicator. Sweat glands are destroyed during coagulation.

 

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 and confirm appropriate depth of treatment such as to avoid bone. Consult with a practitioner to discuss if Ultherapy is right for you.

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, and active implants (e.g., pacemakers or defibrillators) in the treatment area.1

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
  • Implanted electrical devices in the face and/or neck
  • Metal stents in the area of treatment (e.g. face, neck, décolleté (center of chest))
  • Breast implants

Treatment energy is not recommended for use directly on an existing keloid.

The Ulthera System has not been evaluated for use in patients on an anticoagulant treatment plan.

It is recommended that the following areas should be avoided during treatment:

  • Thyroid gland, thyroid cartilage and trachea
  • Major vessels
  • Breast tissue or breast implant

The Ulthera System has not been evaluated for use in the following patient populations:

  • Pregnant or breast-feeding women
  • Children

Those with the following disease states:

  • A hemorrhagic disorder or hemostatic dysfunction
  • An active systemic or local skin disease that may alter wound healing
  • Herpes simplex
  • Autoimmune disease
  • Diabetes
  • Epilepsy
  • Bell’s palsy

Potential Side Effects3

Side effects reported in the clinical evaluation of the Ulthera System for brow and submental and neck treatments 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 hours 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 to 2 days. 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:
    • 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.
    • Transient numbness may result after treatment due to inflammation of a sensory nerve. This typically resolves in 2 to 6 weeks of treatment.
    • 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 have been reported.

  • 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). 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 resolves within 2 hours to 2 days. Tenderness to the touch is also possible and typically resolves within 2 days to 2 weeks of treatment.
  • Welting: The treated area may exhibit a localized area of linear visible edema following treatment. This typically resolves within 1 day to 3 weeks of treatment.
  • Bruising: Mild bruising, which is caused by damage to soft tissue blood vessels, may occur occasionally and typically resolves within 3 days to 3 weeks of treatment.
  • Transient Sensory Nerve Effects (as a result of inflammation of the nerve):
    • Paresthesia and/or numbness may be experienced and typically resolves within 4 days to 5 weeks of treatment.
    • Tingling may result after treatment and typically resolves within 3 to 5 days of treatment.
    • Itching may result after treatment and typically resolves within 1 to 3 weeks of treatment.

    No permanent nerve injuries have been reported.

  • 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). Some scars may respond to medical treatment and resolve fully.

Side effects reported in the clinical evaluation of the Ulthera System for the hyperhydrosis treatment were mild and transient in nature. These were limited to:

  • Bruising: The treated area may exhibit bruising. This typically resolves within 1 day to 3 weeks.
  • Erythema: The treated area may exhibit erythema immediately after treatment. This typically resolves within 1 day.
  • Welting: The treated area may exhibit a localized area of linear visible edema following treatment. This typically resolves within 3 days to 2 weeks.
  • Soreness/Tenderness: The treated area may exhibit soreness or tenderness immediately after treatment. This typically resolves within 3 weeks, however may last longer.
  • Paresthesia/Numbness: The treated area may exhibit paresthesia or numbness immediately after treatment. This typically resolves within 3 weeks, however may last longer.
  • Folliculitis both axilla: The treated area may exhibit folliculitis of the axilla immediately after treatment. This typically resolves within 5 weeks.
  • Induration: The treated area may exhibit induration following treatment. This typically resolves within 11 weeks.
  • Muscle effects such as fatigue, tightness and twitching: The treatment area may exhibit muscle effects following treatment. This typically resolves within 2 weeks.
  • Sensitivity to Touch: The treatment area may exhibit sensitivity to touch following treatment. This typically resolves within 2 weeks.

Complaints and Adverse Events

No serious adverse events were observed during the clinical study evaluation of the Ulthera System.

Ulthera follows Vigilance rules for handling complaints and reporting adverse events. In the event of users having a complaint or if any adverse event occurs or is suspected to have occurred, contact us on the link below
https://ultherapy.com.au/contact/

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1 Instructions for Use

2 Ulthera Public ARTG Summary ARTG ID 225194

3 US IFU