Medical technologies provider InMode has secured an additional 510(k) clearance from the US Food and Drug Administration (FDA) for its Morpheus8 technology, now for contraction of soft tissue.
Morpheus8 is said to be the first and only fractional radiofrequency (FRF) microneedling technology approved for soft tissue contraction.
The clearance allows Morpheus8 to be used in dermatologic procedures requiring soft tissue coagulation/contraction or haemostasis.
It expands Morpheus8’s existing FDA clearance, thereby enhancing its versatility for physicians and patients alike.
Alongside the additional clearance, InMode has launched new IgniteRF and OptimasMAX platforms, which feature the Morpheus8 family of handpieces.
The modular portfolio includes the Prime 12 pin, Resurfacing 24 pin, Morpheus8 24 pin, and Morpheus8 40 pin tips.
The IgniteRF and OptimasMAX platforms support 14 technologies such as minimally invasive radiofrequency for soft tissue coagulation and contraction, intense pulsed light skin treatments, non-invasive thermal radiofrequency, and multi-wavelength hair reduction.
InMode CEO Moshe Mizrahy said: “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.
“The new indication for soft tissue contraction enhances the product’s intended use, helping Morpheus8 practitioners expand their patient base.”
Since its debut, Morpheus8 has been utilised in over 2.5 million procedures worldwide.
InMode specialises in developing, manufacturing, and marketing devices using advanced radiofrequency (RF) technology.
The company has applied its minimally invasive RF technologies to create a range of products across plastic surgery, gynaecology, dermatology, otolaryngology, and ophthalmology fields.
