What the Morpheus8 body applicator is Morpheus8 body work runs on applicators designed for deeper tissue access than the face-focused configurations. The original gen-1 Morpheus8 Body (Blue) applicator and the gen-2 Burst Deep and 90 Applicator are listed in AccessGUDID under InMode Ltd. as the body-oriented members of the family. The FDA cleare...

What is Morpheus8? Morpheus8 is a fractional radiofrequency microneedling system manufactured by InMode Ltd. (Yokneam, Israel). It delivers bipolar RF through coated, insulated microneedles to depths up to 4.0 mm under its original FDA 510(k) clearance, K192695 (December 27, 2019). A second clearance, K240017 (June 13, 2024), added the Morpheus8...

Yes, Scarlet SRF is FDA cleared. It holds a 510(k) clearance under number K180872, listed to manufacturer VIOL Co., Ltd., as a Class II device under product code GEI, the FDA category for electrosurgical cutting and coagulation devices. As with other RF microneedling systems, this is a clearance, not an approval, and it relates to the device as ...