Why do you say Buzzy is for ages 18 months and up?
Buzzy’s vibration is FDA-cleared down to the newborn age, while ice is approved at age 1. Vibration transmission doesn't depend on the thickness of the skin, so the safety is the same for all skin thicknesses and ages. Cold, however, can transmit faster in areas where skin is thin, and children have skin that is thin all over. Because the youngest age that is published with Buzzy showing efficacy with ice was 12 months olds, the FDA's recent clearances would only clear ice down to age 12 months. For our previous 510K, the youngest published study was age 4, so ice was only cleared to this age.
Practically, the ability of children to tolerate ice as they get older. We recommend trying to see if ice is tolerated from age 1 - 4 years. When a child finds ice to be too intense, they can use the soft side, or hold the cold in their hand where the skin is much thicker and still get some of the benefit. For infants, ice on the skin on the thigh can be uncomfortable. Because babies will often cry with newness, it's hard to know if they're tolerating ice there or not. It's difficult to study for these reasons, so we concur with the FDA at this time and recommend Buzzy without ice until one year of age.