The device, along with two treatment handpieces, was approved for use for dermatologic procedures to help reduce mild to moderate facial wrinkles and fractional RF skin resurfacing.
“The GLOW by EndyMed and our 3DEEP technology is already in use by a large number of customers throughout Europe and Asia, and we are very excited to be able to offer it to the U.S. market,” said EndyMed CEO Uzi Blumensohn, in the release. “We receive reports about amazing treatment results and high customer satisfaction levels, and we firmly believe that the GLOW by EndyMed will be a success in the United States as it is in the rest of the world.”
The GLOW will be available in the United States through Eclipse Aesthetics.
EndyMed Medical is headquartered in Caesarea, Israel.
Related Articles on FDA Clearances:
ViewRay Receives FDA 510(k) Clearance for MRI-Guided Radiation Therapy System
Teleflex Receives FDA 510(k) Clearance for Epidural Catheter
ETView Medical Receives FDA 510(k) Clearance for Line of Innovative Airway Devices
At the Becker’s 32nd Annual Meeting: The Business and Operations of ASCs, taking place October 29-31 in Chicago, ASC leaders, surgeons and healthcare executives will explore strategies to drive growth, enhance operational performance, navigate reimbursement challenges and prepare for the future of ambulatory surgery. Apply for complimentary registration now.