1 Laser Drill Machine Pin System 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 Fingertip Pulse Oximeter is certified with the US FDA 510K No. K070371, the CE & TUV of Eureope and it is on the Australian Register of Therapeutic Goods (ARTG) with the code 136606. 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.