FDA Clears CellFX System for the Treatment of SH

September 26, 2022
FDA Clears CellFX System for the Treatment of SH image

The Company also recently received FDA 510(k) clearance of two additional treatment tips with larger spot sizes.

The U.S. Food and Drug Administration (FDA) granted Pulse Bioscience’s CellFX System (FDA) 510(k)marketing clearance for the treatment of sebaceous hyperplasia in patients with Fitzpatrick skin types I-II.

This specific indication clearance enhances the CellFX System’s general indication FDA clearance and enables the Company to support clinics in marketing and promoting CellFX treatments specifically for patients with sebaceous hyperplasia. The clearance was based on clinical data from the Company’s IDE approved study for the treatment of sebaceous hyperplasia.

The Company also recently received FDA 510(k) clearance of two additional treatment tips with larger spot sizes, specifically 7.5mm and 10mm tip sizes, for treating larger benign lesions. These treatment tips broaden the portfolio of previously available 1.5mm, 2.5mm and 5.0mm treatment tip sizes.

“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,” says Kevin Danahy, President and Chief Executive Officer of Pulse Biosciences, in a news release.  “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.”

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