Pulse Biosciences Scores FDA 510(k) Clearance of Expanded Energy Settings for CellFX System

Pulse Biosciences’s proprietary Nano-Pulse Stimulation technology delivers nano-second pulses of electrical energy to non-thermally clear cells while sparing adjacent non-cellular tissue.

The U.S. Food and Drug Administration (FDA) gave 510(k) clearance tp expanded energy settings for use with Pulse Biosciences, Inc.’s CellFX System treatments tips in dermatology.

“Pulse Biosciences is dedicated to providing dermatologists a superior 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,” says Darrin Uecker, President and Chief Executive Officer of Pulse Biosciences, in a news release. “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.”

Learn more about the CellFX system from Mr. Uecker in this episode of Scientifically Speaking.

Pulse Biosciences’s 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.