Pulse Biosciences Seeking 510(K) Approval for CellFX Nanopulse Stimulation System

Pulse Biosciences seeks 501(k) approval

Pulse Biosciences has made a Premarket Notification 510(k) submission to the U.S. Food and Drug Administration (FDA) for its CellFX System, which features the company’s proprietary Nano-Pulse Stimulation (NPS) technology. The filing requests clearance of the CellFX System for commercial use in common dermatologic procedures to remove general benign lesions, including sebaceous hyperplasia (SH) and seborrheic keratosis (SK).