#FDA510k
2 articles
Ultherapy Depths Explained: 1.5, 3.0 and 4.5 mm and What the 8 mm Screen Shows
The FDA 510(k) summary for K180623 lists the energy of a single Ulthera pulse at under 2 joules. The same filing places the device in Class II under 21 CFR…
Volnewmer vs Thermage: 115 W vs 400 W at the Same 6.78 MHz
Four hundred watts and 115 watts. Those two figures sit side by side in the comparison table of FDA 510(k) summary K240248, one column for the predicate…