Pulse Biosciences’ CellFX Gets 510(k) Clearance for Expanded Energy Settings
Hayward, Calif.-based Pulse Biosciences has received 510(k) clearance from the FDA for the use of expanded energy settings in its CellFX system for treatment of benign skin lesions.
The company’s proprietary technology delivers nano-second pulses of electrical energy to the lesions while sparing adjacent tissue.
The system features a multi-use handpiece and a range of single-patient use treatment tips to accommodate a variety of lesion sizes. It also includes automated treatment settings depending on the tip used in the treatment.
The clearance was supported by study data showing that the increased energy settings are safe and effective for use, the company said.