9b39a3e9-3fe5-4d02-bbc8-d16985f20203NewPublished12026-05-192026-05-11In Commercial DistributionG710A480PrimaryHIBCCVelara Ascend 48A48A48104258633SUNSHINE USA, LLC1This is a Class II infrared therapeutic heating lamp (Product Code ILY, 21 CFR 890.5500) intended for localized heat therapy to relieve muscle pain, joint stiffness, and improve local blood circulation.falsetruefalsefalsefalsefalsefalsetruefalsefalsefalsefalsefalseLabeling does not contain MRI Safety Informationfalsefalse65723Red/infrared light phototherapy unitAn electrically-powered device designed to emit red light and infrared/near-infrared light for phototherapy primarily to accelerate healing of cutaneous/mucosal tissues and/or to treat musculoskeletal symptoms (e.g., pain, spasm, stiffness) through modification of cellular metabolism and/or improvement of blood flow. It may have various designs (e.g., hand-held, arched bar, flexible pad for adapting to body areas) and is intended for use in the home and clinical settings.falseActiveILYLamp, Infrared, Therapeutic Heatingfalsefalse