Home » FDA Down-Classifies Focused Ultrasound Stimulators
FDA Down-Classifies Focused Ultrasound Stimulators
The FDA is down-classifying the focused ultrasound stimulator system for aesthetic use into class II. The reclassification comes in response to a petition filed by Ulthera in 2008 after Ulthera, its ultrasound stimulator device, was deemed class III because it had no predicate.
Devices & Diagnostics Letter
Devices & Diagnostics Letter
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