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FDA Grants 510(k) Clearance to Morpheus8 for Soft Tissue Contraction

The U.S. Food and Drug Administration (FDA) has cleared InMode’s Morpheus8 Applicators for the delivery of fractional radiofrequency use in dermatologic skin procedures where coagulation/contraction of soft tissue or hemostasis is needed.

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 includes Prime 12 pin, Morpheus8 24 pin, Resurfacing 24 pin, and Morpheus8 40 pin.  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.

“InMode is dedicated to investing in R&D so we can provide medical professionals with continued advancements they need to deliver the highest quality of care and best-in-class results,” says Moshe Mizrahy, CEO of InMode, in a news release. “The new indication for soft tissue contraction enhances the product’s intended use, helping Morpheus8 practitioners expand their patient base.”