Michael Barbella, Managing Editor09.09.22
Pulse Biosciences Inc. has received U.S. Food and Drug Administration (FDA) 510(k) clearance of expanded energy settings for use with CellFX System treatments tips in dermatology.
“Pulse Biosciences is dedicated to providing dermatologists a solution for the treatment of benign lesions and to advancing the CellFX System and its capabilities. Clinicians in the U.S. are now able to access broader treatment settings to provide more customized energy delivery specific to individual lesions,” said Darrin Uecker, president and CEO of Pulse Biosciences. “We are pleased with how quickly the FDA cleared these new energy settings based on the data we provided, requiring 53 of the allotted 90-day review period, to determine that the expanded settings are safe and effective for use with the CellFX System. We appreciate the ongoing collaboration with FDA as we continue to expand the clinical applications for the CellFX System.”
Pulse Biosciences is a novel bioelectric medicine company whose proprietary Nano-Pulse Stimulation technology delivers nano-second pulses of electrical energy to non-thermally clear cells while sparing adjacent non-cellular tissue. The CellFX System is the first commercial product to harness the distinctive advantages of NPS technology to treat a variety of applications for which an optimal solution remains unfulfilled. The initial commercial use of the CellFX System is to address a range of dermatologic conditions that share high demand among patients and practitioners for improved dermatologic outcomes.
Pulse Biosciences, CellFX, Nano-Pulse Stimulation, NPS are among the trademarks and/or registered trademarks of Pulse Biosciences Inc. in the United States and other countries.
“Pulse Biosciences is dedicated to providing dermatologists a solution for the treatment of benign lesions and to advancing the CellFX System and its capabilities. Clinicians in the U.S. are now able to access broader treatment settings to provide more customized energy delivery specific to individual lesions,” said Darrin Uecker, president and CEO of Pulse Biosciences. “We are pleased with how quickly the FDA cleared these new energy settings based on the data we provided, requiring 53 of the allotted 90-day review period, to determine that the expanded settings are safe and effective for use with the CellFX System. We appreciate the ongoing collaboration with FDA as we continue to expand the clinical applications for the CellFX System.”
Pulse Biosciences is a novel bioelectric medicine company whose proprietary Nano-Pulse Stimulation technology delivers nano-second pulses of electrical energy to non-thermally clear cells while sparing adjacent non-cellular tissue. The CellFX System is the first commercial product to harness the distinctive advantages of NPS technology to treat a variety of applications for which an optimal solution remains unfulfilled. The initial commercial use of the CellFX System is to address a range of dermatologic conditions that share high demand among patients and practitioners for improved dermatologic outcomes.
Pulse Biosciences, CellFX, Nano-Pulse Stimulation, NPS are among the trademarks and/or registered trademarks of Pulse Biosciences Inc. in the United States and other countries.