Sam Brusco, Associate Editor09.26.22
Bioelectric medicine company Pulse Biosciences has earned U.S. Food and Drug Administration 510(k) clearance for its CellFX system that expands its indication to treating sebaceous hyperplasia for patients with Fitzpatrick skin types I-II.
The FDA nod was based on data from the firm’s IDE approved study to treat sebaceous hyperplasia. The company also earned 510(k) nods for two treatment tips with 7.5mm and 10mm tip sizes to treat larger benign lesions.
The CellFX system is powered by the company’s proprietary Nano-Pulse Stimulation (NPS) technology.
“We are pleased with the continued advancement of the CellFX System and its capabilities to enhance its value proposition for patients, clinicians and any potential commercial partner. These clearances provide further validation of the system’s strong safety and effectiveness profile,” Kevin Danahy, president and CEO of Pulse Biosciences told the press. “We would like to thank all of the investigators, the staff at their clinics and the patients who participated in these trials, as well as the FDA for their ongoing collaboration as we endeavor to offer the benefits of NPS technology to more patients.”
The FDA nod was based on data from the firm’s IDE approved study to treat sebaceous hyperplasia. The company also earned 510(k) nods for two treatment tips with 7.5mm and 10mm tip sizes to treat larger benign lesions.
The CellFX system is powered by the company’s proprietary Nano-Pulse Stimulation (NPS) technology.
“We are pleased with the continued advancement of the CellFX System and its capabilities to enhance its value proposition for patients, clinicians and any potential commercial partner. These clearances provide further validation of the system’s strong safety and effectiveness profile,” Kevin Danahy, president and CEO of Pulse Biosciences told the press. “We would like to thank all of the investigators, the staff at their clinics and the patients who participated in these trials, as well as the FDA for their ongoing collaboration as we endeavor to offer the benefits of NPS technology to more patients.”