Pulse Biosciences Receives FDA Clearance For The Treatment Sebaceous Hyperplasia

(RTTNews) - Pulse Biosciences, Inc. (PLSE), a bioelectric medicine company, has received FDA clearance for its CellFX System to expand the indication for use in the treatment of sebaceous hyperplasia in patients with Fitzpatrick skin types I-III.

The CellFX system, based on the company's patented Nano-Pulse Stimulation technology, delivers ultrafast energy pulses to the skin lesions

In the United States, the CellFX System is already cleared for dermatologic procedures requiring ablation and resurfacing of the skin and intended use of treating benign lesions. Today's clearance for the specific indication allows for the marketing of CellFX treatments specifically for patients with sebaceous hyperplasia.

Sebaceous hyperplasia is a disorder of sebaceous glands in which they become enlarged and sebum is trapped in them. It results in skin-colored bumps on the skin.

The Fitzpatrick Skin Type is a skin classification system first developed in 1975 by Thomas Fitzpatrick, MD, of Harvard Medical School. There are six skin phototypes, going from light to dark. Source: Journal de Médecine Esthétique, 1975.

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