FDA 510(K) CLEARED. The standard that everything else is measured against. The Orvelle ClinicalPro Mask carries FDA clearance — the same regulatory certification required of Class II medical devices in the United States. Four precisely calibrated wavelengths: red (660nm), blue (460nm), yellow (590nm), and near-infrared (850nm). High-density LED array for full-face coverage. 2000mAh polymer battery, magnetic charging, food-grade silicone + ABS alloy.
