www.fdanews.com/articles/138685-fda-down-classifies-focused-ultrasound-stimulators
FDA Down-Classifies Focused Ultrasound Stimulators
July 26, 2011
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