FDA clears first fractional radiofrequency microneedling tool for soft tissue contraction
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Key takeaways:
- The FDA cleared Morpheus8 for contraction of soft tissue.
- This is the first and only fractional radiofrequency microneedling technology approved for this indication.
The FDA has cleared the first and only fractional radiofrequency microneedling technology for contraction of soft tissue, InMode Ltd. announced in a press release.
Morpheus8 Applicators are used for the delivery of fractional radiofrequency in dermatologic skin procedures where coagulation or contraction of soft tissue or hemostasis is needed. The FDA’s clearance of these applicators expands Morpheus8’s existing FDA clearance.
“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,” Moshe Mizrahy, CEO of InMode, said in the release. “The new indication for soft tissue contraction enhances the product’s intended use, helping Morpheus8 practitioners expand their patient base.”
In addition to the clearance of this microneedling device, the company has announced the launch of its new IgniteRF and OptimasMAX platforms, which include Morpheus8 handpieces. These platforms support the same indications as Morpheus8 as well as intense pulsed light skin treatments and multi-wavelength hair reduction.
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