IRVINE,
Calif., July 17, 2024 /PRNewswire/ -- 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.
"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,"
said Moshe Mizrahy, CEO of InMode.
"The new indication for soft tissue contraction enhances the
product's intended use, helping Morpheus8 practitioners expand
their patient base."
Since inception, Morpheus8 has gained widespread global brand
awareness, with more than 2.5 million procedures performed
worldwide, and an average of 8.2 treatments performed every minute.
The Morpheus8 brand has become so popular that consumers and
celebrities request it by name. It is a trusted procedure known for
delivering both natural and striking results.
About InMode
InMode is a leading global provider of innovative medical
technologies. InMode develops, manufactures, and markets devices
harnessing novel radiofrequency ("RF") technology. InMode strives
to enable new emerging surgical procedures as well as improve
existing treatments. InMode has leveraged its medically accepted
minimally invasive RF technologies to offer a comprehensive line of
products across several categories for plastic surgery, gynecology,
dermatology, otolaryngology, and ophthalmology. For more
information about InMode and its wide array of medical
technologies, visit www.inmodemd.com.
Press Contact:
Behrman Cesa Communications
inmode@behrmancesa.com
Investor Contact:
MS-IR LLC
Miri Segal – Scharia
ir@inmodemd.com
Tel: 917-607-8654
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SOURCE InMode Ltd.