- The shares of healthcare equipment maker Pulse Biosciences, Inc. ( NASDAQ: PLSE ) added ~14% pre-market Monday after the company announced that the FDA issued 510(k) clearance for its CellFX System expanding its use to treat the skin condition sebaceous hyperplasia.
- The regulator had previously issued the 510(k) clearance for CellFX in Feb. 2021 for dermatologic procedures requiring ablation and resurfacing of the skin.
- The latest authorization expands its use to treat sebaceous hyperplasia in patients with Fitzpatrick skin types I-III.
- Additionally, the company announced that the FDA granted 510(k) clearance for two more treatment tips used in the CellFX System. The decision to greenlight tips with larger spot sizes expands the PLSE’s product portfolio to five treatment tip sizes.
For further details see:
Pulse Biosciences wins FDA clearance to expand use of CellFX System