Candela GentleMax

The original Candela GentleMax is a dual wavelength hair removal and dermatology laser that houses a 755 nm alexandrite head and a 1064 nm Nd:YAG head in one cabinet. It began as the Candela 3630 Laser System, cleared by FDA under K063074 in December 2006, and Candela's 2011 filing K112715 notes that the 3630 was renamed GentleMAX. The two beams are combined on an internal rail so that a single fiber and handpiece deliver either wavelength, and each head has its own switch that decides which one fires. Laser Focus World reported its approval in China in 2010.

The FDA summaries describe flashlamp excited laser rods, a self contained water circuit with a water to air heat exchanger, a touch screen, and a lens-coupled fiber that the user can replace. Pulse durations run from 0.25 to 300 ms, repetition rates reach 10 pulses per second depending on pulse width, and the handpieces produce round spots of 1.5, 3, 6, 8, 10, 12, 15 and 18 mm. Skin cooling comes from the Dynamic Cooling Device, which sprays cryogen held inside the cabinet through a hose to a nozzle on the handpiece.

Candela later modified the family into the GentleMax Pro, which FDA cleared as a modified GentleMAX in December 2013 (K133283), and the GentleMax Pro Plus followed in 2020. GUDID lists the original consoles under model numbers such as 9914-00-0400, 9914-00-0402, 9914-00-0410 and 9914-00-0420, plus GentleMax Limited Edition units such as 9914-00-0330, all now out of commercial distribution. A label reading GentleMax Pro, 9914-00-9035, is the newer model.

Buyers will ask for the pulse counts on both heads, when flashlamps were last changed, and whether the water circuit has been serviced. Report the fiber and handpiece window condition, the cryogen canister, every handpiece and spot size included, and the software version. Photograph the serial label and the main screen.