The FDA Has Cleared Candela’s Vbeam Pulsed Dye Laser for Pediatric Port Wine Stains and Hemangiomas 

The Candela Corporation’s Vbeam 595 nm Pulsed Dye Laser (PDL) has been cleared by the U.S. Food and Drug Administration (FDA) to treat port wine stains (PWS) and hemangiomas in pediatric patients.


The device has already been approved for adults as a first-line treatment for hemangiomas and port wine stains, but its use has now been expanded to include the pediatric population from birth to those aged 21 years old. It is the first device of its kind to be made available to pediatric patients.

PWS, which affects one in 300 children, usually gets darker and thicker over time. Hemangiomas are also believed to grow rapidly during the first few months of life. As such early treatment is critical in order to obtain optimal results.

The FDA clearance comes after the publication of 33 peer-reviewed studies conducted globally revealed that the Vbeam 595 nm PDL was both gentle enough for use in over 6000 pediatric patients and powerful enough to deliver effective results. Furthermore, treatment can be done during infancy without the use of general anesthesia.

Board-certified dermatologist and director of Laser & Skin Surgery Center of New York®, Roy G. Geromemus, MD, provided a recommendation letter to the FDA for clearance of Candela’s Vbeam Family of 595 nm PDLs in the pediatric population. He states, “I am fortunate to be one of the original investigators in the use of the pulsed dye laser for cutaneous vascular lesions close to forty years ago. Since that time, the focus of my clinical research and clinical practice has been the treatment of port wine stains and hemangiomas in infants and children. My most recent study of 197 infants with port wine stains under the age of 1 year showed dramatic clearing and the highest incidence of clearing to date.”


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