FDA expands indication of CellFX System to include patients with sebaceous hyperplasia

Pulse Biosciences has announced it received FDA 510(k) clearance for expanding the use of its CellFX System to treat sebaceous hyperplasia in patients with Fitzpatrick skin types I to III, according to a company press release.

“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,” Kevin Danahy, MS, president and CEO of Pulse Biosciences, said in the press release. “These clearances provide further validation of the system’s strong safety and effectiveness profile.”

The clearance was based on an investigational device exemption study conducted for the treatment of sebaceous hyperplasia. The company also recently received FDA clearance for the use of two additional treatment tips with larger spot sizes — 7.5 mm and 10 mm — for the treatment of larger lesions, which adds to the previously available 1.5 mm, 2.5 mm and 5 mm tip sizes.

“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,” Danahy said.