Pulse Biosciences Gets Expanded 510(k) Clearance for CellFX System
Pulse Biosciences has received an expanded 510(k) clearance from the FDA for its CellFX System for treatment of sebaceous hyperplasia — an enlargement of the skin oil glands — in patients with Fitzpatrick skin types I-III.
The device uses patented nano-pulse stimulation to treat benign lesions, delivering nanosecond pulses of electrical energy to non-thermally clear cells while sparing the adjacent tissue. It includes a variety of treatment tips to deal with different lesion sizes.
The company recently received FDA clearance of 7.5mm and 10mm treatment tips for treating larger benign lesions, adding to the previously cleared 1.5mm, 2.5mm and 5.0mm tip sizes.