Document Detail

Medical devices; general and plastic surgery devices; classification of the focused ultrasound stimulator system for aesthetic use. Final rule.
MedLine Citation:
PMID:  21774154     Owner:  HSR     Status:  In-Process    
The Food and Drug Administration (FDA) is classifying the focused ultrasound stimulator system for aesthetic use into class II (special controls). The special control(s) that will apply to the device is the guidance document entitled "Class II Special Controls Guidance Document: Focused Ultrasound Stimulator System for Aesthetic Use." The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Federal register     Volume:  76     ISSN:  0097-6326     ISO Abbreviation:  Fed Regist     Publication Date:  2011 Jul 
Date Detail:
Created Date:  2011-07-20     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  7808722     Medline TA:  Fed Regist     Country:  United States    
Other Details:
Languages:  eng     Pagination:  43119-21     Citation Subset:  T    
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