Candela is excited to announce that its legacy Vbeam 595 nm Pulsed Dye Laser (PDL) is now indicated to include the pediatric population, the first clearance of its kind.
The Vbeam Family of Pulsed Dye Lasers has expanded its FDA indications to include the pediatric population for the treatment of port wine stains (PWS), and infantile hemangiomas (IH) / congenital hemangiomas with the 595 nm wavelength.*
The Vbeam 595 nm PDL is world recognized as the gold standard treatment for PWS,1,2 and the primary choice for hemangioma treatment in pediatric patients.3,4 The Vbeam 595 nm PDL incorporates the optimal wavelength to penetrate the target vessels, optimal pulse durations for heating of larger caliber blood vessels, and epidermal protection with its pioneering dynamic cooling device (DCD™) to deliver greater clinical efficacy.
With decades of proven results and lives changed, Candela is dedicated to progressive innovation, and this one-of-a-kind clearance is a monumental part of our mission.
Download the Clinical Bulletin to learn more about the clinical evidence for the FDA clearance of the Vbeam 595 nm PDL to treat the pediatric population for PWS and hemangiomas.
*Candela Vbeam Family of Pulsed Dye Lasers (Vbeam Prima, Vbeam Perfecta) 510(k) clearance [K230990], June, 2023.
References
1. Brauer JA, Farhadian JA, Bernstein LJ, Bae YS, Geronemus RG. Pulsed Dye Laser at Subpurpuric Settings for the Treatment of Pulsed Dye Laser-Induced Ecchymoses in Patients With Port-Wine Stains. Dermatol Surg. 2018 Feb;44(2):220-226.
2. Jeon H, Bernstein LJ, Belkin DA, Ghalili S, Geronemus RG. Pulsed Dye Laser Treatment of Port-Wine Stains in Infancy Without the Need for General Anesthesia. JAMA Dermatol. 2019 Apr 1;155(4):435-441.
3. Zhang W, Li F, Yang Y, Xue L, Cao M, Wang L. Hemangioma treatment with pulsed dye laser-distinct parameters used between neonatal and non-neonatal patients. J Cosmet Laser Ther. 2016 Nov;18(7):389-392.
4. Yang B, Li L, Zhang LX, Sun YJ, Ma L. Clinical Characteristics and Treatment Options of Infantile Vascular Anomalies. Medicine (Baltimore). 2015 Oct;94(40):e1717. doi:10.1097/MD.0000000000001717.
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