By Will Feuer


Pulse Biosciences Inc. said it has received 510(k) clearance from the U.S. Food and Drug Administration for its CellFX System that expands the indication for use to include the treatment of sebaceous hyperplasia in patients with Fitzpatrick skin types I-III.

Sebaceous gland hyperplasia occurs frequently in older individuals, particularly in men past middle age, according to the National Institutes of Health. It presents as one or more elevated, soft, yellow papules with central umbilication on the face, particularly the forehead. Lesions may spread to the neck and upper part of the thorax.

Pulse Biosciences said it 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 clearances provide further validation of the system's strong safety and effectiveness profile," Pulse Biosciences Chief Executive Kevin Danahy said.

Shares of Pulse Biosciences rose almost 11% to $1.69 in premarket trading.


Write to Will Feuer at


(END) Dow Jones Newswires

September 26, 2022 08:50 ET (12:50 GMT)

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