Summary: The U.S. FDA has granted additional 510(k) clearance for Morpheus8 for soft-tissue contraction, coinciding with the launch of the IgniteRF and OptimasMAX platforms.
Key Takeaways
- The FDA has granted additional clearance for Morpheus8 for soft-tissue contraction and dermatologic skin procedures requiring coagulation or contraction of soft tissue or hemostasis.
- InMode has launched the IgniteRF and OptimasMAX platforms, featuring a range of Morpheus8 handpieces and supporting 14 different technologies for various treatments.
- Morpheus8 has performed over 2.5 million procedures worldwide, averaging 8.2 treatments per minute.
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The U.S. FDA has granted additional 510(k) clearance for Morpheus8, a fractional radiofrequency microneedling technology, for soft-tissue contraction. The Morpheus8 Applicators are also cleared for dermatologic skin procedures requiring coagulation or contraction of soft tissue or hemostasis, expanding the technology’s existing clearance.
Launch of New IgniteRF and OptimasMAX Platforms
Coinciding with this clearance is the launch of the new IgniteRF and OptimasMAX platforms, which include the Morpheus8 line of handpieces. The modular portfolio includes Prime 12 pin, Morpheus8 24 pin, Resurfacing 24 pin, and Morpheus8 40 pin tips, making the technology versatile. 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.”
Expanding Patient Base for Morpheus8 Practitioners
“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 InMode CEO Moshe Mizrahy. “The new indication for soft tissue contraction enhances the product’s intended use, helping Morpheus8 practitioners expand their patient base.”
Company officials add that Morpheus8 has performed over 2.5 million procedures worldwide, averaging 8.2 treatments per minute.
