900df90e-b156-4846-9ff8-eac8f15d3c1bUpdatePublished22025-05-222023-06-06In Commercial DistributionE2352171B1Unit of UseHIBCCE235DL0010PrimaryHIBCCDentaLaze KitDL001DL001054618202SHOFU DENTAL CORPORATION10DentaLaze Diode Laser Kit with the following content: Laser Handpiece (Main Control & Battery), 2 goggles, 1 laser shield, 5 fiber tips, 50 laser sheaths, 1 charging stand, 1 power adapter, IFU, Box Oversleeve, Labels: box, fiber tips, charging stand, Danger sign falsefalsefalsefalsefalsefalsetruefalsefalsefalsefalsefalsefalseLabeling does not contain MRI Safety Informationtruefalse760-736-3277customer-service@shofu.comK20138700060341General/multiple surgical diode laser systemAn electrically-powered device assembly in which input energy is used to excite a diode to emit a high-power therapeutic laser beam intended to incise, excise, ablate, vaporize and coagulate tissues for general surgery and/or multiple specialized surgical applications (non-dedicated) such as lipolysis, endovenous laser therapy (EVLT), percutaneous laser disc decompression (PLDD), benign prostatic hyperplasia (BPH) therapy, and ear/nose/throat (ENT) interventions. It includes a diode laser light source, flexible fibreoptic delivery cable, and controls/foot-switch.falseActiveNVKLaser, Dental, Soft TissuefalsetrueMoist Heat or Steam Sterilization