FDA Asks Pulse Biosciences for More Proof in 510(k) Submission for Its CellFX System

Pulse Biosciences says its application for an expanded 510(k) clearance for its bioelectric CellFX system with nano-pulse stimulation technology has prompted a request from the FDA for more supporting evidence.

The 510(k) submission is seeking clearance to add an indication for treatment of sebaceous hyperplasia, a common skin condition in older adults, to the CellFX System’s labeling.

The FDA said it did not believe the company provided enough clinical evidence to support the expanded indication for use, as the system had not met primary endpoints in an FDA-approved investigational device exemption study.

The CellFX System is cleared in the U.S. for dermatologic procedures requiring ablation and resurfacing of the skin, as well as treating benign lesions. It is already approved in the EU for treatment of sebaceous hyperplasia, seborrheic keratosis and nongenital warts.