Ulthera DeepSEE DS 4 - 4.5, Instructions For Use Manual

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Ulthera, Inc.
2.7. 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.