Pulse Biosciences Announces FDA 510(k) Clearance for the Treatment of Sebaceous Hyperplasia
Pulse Biosciences, Inc (PLSE)
Last pulse biosciences, inc earnings: 11/7 03:42 pm
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Source: Business Wire
Additional 510(k) clearance recently received for use of larger spot size treatment tips with the CellFX System HAYWARD, Calif.--(BUSINESS WIRE)--Pulse Biosciences, Inc. (Nasdaq: PLSE), a novel bioelectric medicine company developing the CellFX® System powered by Nano-Pulse Stimulation™ (NPS™) technology, today announced receipt of U.S. Food and Drug Administration (FDA) 510(k) clearance for its CellFX System, expanding the indication for use to include the treatment of sebaceous hyperplasia in patients with Fitzpatrick skin types I-III. 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 wi
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