Candela GentleLase Pro

The Candela GentleLase Pro is a single wavelength 755 nm alexandrite laser, and Candela's company timeline lists its launch in 2011. FDA cleared the GentleLASE family, covering the GentleLase Pro and the GentleLase Pro LE, under K140732 in November 2014. The summary describes an alexandrite laser head feeding an optical fiber and handpiece, with air or cryogen skin cooling. Cleared uses include hair reduction, including permanent hair reduction, benign pigmented lesions, wrinkles and the photocoagulation of vascular lesions such as port wine stains, hemangiomas and telangiectasias.

The standard delivery system covers spot sizes of 6, 8, 10, 12, 15 and 18 mm. Candela lists up to 53 J of delivered energy and pulse durations from 0.25 to 100 ms. Two optional delivery systems extend that range: a small spot set at 1.5, 3, 5 mm and a 3 x 10 mm spot, and a large spot set at 20, 22 and 24 mm. Cooling comes from either the cryogen-based Dynamic Cooling Device or an Air Cooling Compatible handpiece. FDA's device database lists delivery systems as separate parts, such as a 12, 15 and 18 mm set with DCD.

The FDA summary says the Pro and Pro LE differ only in side panel color. Later Candela material calls the system the GentleLase Pro-U and offers a 1064 nm Nd:YAG upgrade. A console that offers 1064 nm on the screen has either been upgraded or is a GentleMax Pro, which ships with both wavelengths.

The serial label settles the question: FDA recall records give model 9914-00-9015 for the Pro and 9914-00-9040 for the Pro LE. Those consoles were the subject of a Class 2 recall in November 2013, traced to software design, that FDA closed in June 2015, so buyers will want the service history to confirm the correction was applied. They will also ask about the pulse count, the fiber and handpiece condition, and which delivery systems are included.