INSTRUCTIONS FOR USE

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Indications for Use

The Ulthera System is indicated for use as a non-invasive dermatological aesthetic treatment to:

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:

Contraindications

The Ulthera System is contraindicated for use in patients with:

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:

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:

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

Patient Safety

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:

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:

Complaints and Adverse Events

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

Ulthera follows MDR (Medical Device Reporting) rules for handling complaints and adverse events. Should an adverse event be suspected or reported, contact Ulthera, Inc. at 480-619- 4069; for those outside the U.S., contact your local Ulthera representative.

Post Market Surveillance

The following adverse events have been identified during routine clinical use following FDA clearance (post market) of the Ulthera system. Because they are reported voluntarily from a population of uncertain size it is not always possible to reliably estimate their frequency or establish a causal relationship to the Ulthera system. These events have been chosen for inclusion due to a combination of their seriousness, frequency of reporting, or potential causal connection to the Ulthera system: pain, burns, or burning sensation, edema / swelling, nodules, bruising, fat / volume loss, neuropathy, numbness, paresthesia, palsy, paresis, speech difficulty, muscle weakness, headache, migraine, visual change, skin sagging / drooping, asymmetry, erythema, welts, hives, rash, urticaria, pruritus, blistering, scarring, discoloration and hyperpigmentation.

NOTE:
This document is for web purposes only. It has been condensed from its original version. For additional information, contact 1.877.ULTHERA.

1004006 IFU Rev. B