An ultrasonic irradiation device according to the disclosure includes: an ultrasonic transducer for external application of focused ultrasound to a body surface； and a tenderness level meter comprising a pressing element that presses the body surface, a pressing unit that presses the pressing element against the body surface, a load measuring unit that measures a pressing force exerted on the body surface by the pressing element, and a pressure recorder for tenderness perception that records a pressing force at which a pressing action of the pressing element causes pain perception. This makes it possible to measure a tenderness level of an ultrasonic irradiation target area without moving an HIFU transducer (1) from above an affected area.
