FDA-Device2018-03-07Class II
REVOLVE ADVANCED ADIPOSE SYSTEM, for aspiration, harvesting, filtering, and transferring of autologous adipose tissue for aesthetic body contouring.
Hazard
Presence of bacterial endotoxins levels above the acceptable limit
Sold states
US Nationwide, Canada, Australia, Chile, Brazil, Israel, Japan New Zealand & Singapore
Affected count
25,798 units
Manufactured in
1 Millennium Way, N/A, Branchburg, NJ, United States
Products
REVOLVE ADVANCED ADIPOSE SYSTEM, for aspiration, harvesting, filtering, and transferring of autologous adipose tissue for aesthetic body contouring.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0823-2018Don't want to check this manually?
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