Category
Devices & Technologies
Technology, regulatory status and safety concepts for HIFU, radiofrequency, laser and other energy-based devices.
4 terms
Exilis Ultra is an FDA 510(k) approved zero-downtime non-invasive body contouring and facial tightening combination device produced by BTL Aesthetics, delivering 1-3 MHz monopolar radiofrequency (RF) and 2 MHz ultrasonic energy simultaneously, providing real-time impedance control with Proteus technology, for sub-dermal 4-10 mm deep fat tissue heating and dermal collagen coagulation.
HIFU is a category of devices that delivers focused ultrasound energy to tissue depths defined by the exact system and cartridge; aesthetic candidacy, expected response, and regulatory status must be assessed through the specific model, intended use, and an in-person examination rather than through the technology name alone.
Morpheus8 is a fractional RF microneedling medical device produced by InMode Aesthetic Solutions, which will transmit bipolar radiofrequency energy to the subdermal layer at a depth of 1-8 mm through an insulated microneedle array (12-40 pins), performs thermal remodeling in the dermis collagen and subdermal adipose tissue, and is used for facial contouring, skin tightening and body contouring with Subdermal Adipose Remodeling (SART) FDA approval.
Thermage FLX is an FDA 510(k) approved non-invasive skin tightening device produced by Solta Medical, which triggers immediate collagen contraction (immediate tightening) and subsequent neocollagenesis by volumetric heating in the skin dermis layer with 6 MHz monopolar radiofrequency (RF) energy, and offers impedance-compatible energy regulation with the AccuREP algorithm.