InMode Ltd. (NASDAQ: INMD), a leading global provider of innovative medical technologies, is pleased to announce an additional FDA 510(k) clearance for the Morpheus8 technology. Morpheus8 is the first and only fractional radiofrequency (FRF) microneedling technology cleared for contraction of soft tissue.
The U.S. Food and Drug Administration (FDA) has cleared the use of the Morpheus8 Applicators for the delivery of fractional radiofrequency use in dermatologic skin procedures where coagulation/contraction of soft tissue or hemostasis is needed. This FDA action expands Morpheus8’s existing FDA clearance, emphasizing the versatility of the technology for physicians and patients.
Coinciding with this clearance is the launch of the new IgniteRF and OptimasMAX platforms, which include the Morpheus8 family of handpieces. The modular portfolio of tips, including Prime 12 pin, Morpheus8 24 pin, Resurfacing 24 pin, and Morpheus8 40 pin, makes this technology a versatile solution delivering exceptional patient results. The IgniteRF and OptimasMAX platforms support 14 technologies, including minimally invasive radiofrequency assisted soft tissue coagulation and contraction, non-invasive thermal radiofrequency, intense pulsed light skin treatments, and multi-wavelength hair reduction.
