FDA Clears Pulse Biosciences’ Cell FX System

The FDA has granted Hayward, Calif.-based Pulse Biosciences 510(k) marketing clearance for its Cell FX, a nano-pulse stimulation device used for skin-ablation procedures.

The CellFX system delivers nano-second pulses of electrical energy to clear unwanted cellular structures while avoiding damage to surrounding healthy skin.

The company said it will begin a commercial launch of the nano-pulse stimulation system in the U.S. “in the coming weeks.” The system, which recently earned CE mark certification, is already available in Europe.