Device typeRadio-frequency skin surface treatment system: An assembly of devices designed to apply radio-frequency (RF) energy to heat the skin surface for ablation, coagulation, and tightening of the skin’s outer later (stratum corneum) for aesthetic skin resurfacing. It primarily consists of a mains electricity (AC-powered) control unit to produce and regulate the RF energy, and a connected bipolar RF applicator (handpiece) to deliver the RF energy to the skin surface; the applicator may include vacuum to facilitate its coupling with the skin.
FDA categoryOver-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction
Device ID05060445341125
AvailabilityOver the counter
MRI safetyLabeling does not contain MRI Safety Information