Tool for any dental office. FDA declaration : Statement:The sale of this item may be subject to regulation by the U. Food and Drug Administration and state and local regulatory agencies. The Powered Surgical Instrument / Speed 808 System is certified with the US FDA 510(k) Number:K132989 The Powered Surgical Instrument / Hair Remove Device is certified with the US FDA 510(k) Number:K180353 The Powered Surgical Instrument / Hair Remove System is certified with the US FDA 510(k) Number:K141973 massager, vacuum, light induced heating / Slimming Treatment Device is certified with the US FDA 510(k) Number:K161892.