Candela GentleYAG

The Candela GentleYAG is a flashlamp excited, long pulse Nd:YAG laser at 1064 nm. It entered the market as the Candela Long Pulse Nd:YAG, cleared by FDA under K010104 in April 2001, and Candela's 2003 family filing K033172 states that GentleYAG is the same laser, also known as the Long Pulse Nd:YAG. Additional clearances followed in quick succession: pseudofolliculitis barbae (K023193) in December 2002 and facial wrinkles (K022951) in January 2003, and the broader GentleYAG family clearance in October 2003. That last one covers hair removal and permanent hair reduction on Fitzpatrick types I to VI, vascular and pigmented lesions including leg and spider veins, and soft tissue coagulation.

The 2002 summaries list the hardware as a console with software and control electronics, a control and display panel, a lens-coupled optical fiber handpiece that the user can replace, a skin cooling device built into the handpiece, a footswitch or handswitch, and a remote interlock connector. The 2003 summary adds an aiming beam in the handpiece and lists cooling as optional.

GentleYAG consoles in FDA's GUDID database carry model numbers in the 9914-xx-09xx and 9914-xx-10xx ranges, for example 9914-00-0950, 9914-08-0951 and 9914-09-1031, and there is also a GentleYAG LE version. Several early numbers left commercial distribution in June 2024. The later GentleYAG Pro-U uses 9914-00-9020 and the GentleYAG Pro uses 9914-00-9320, so the label separates the generations. A console that also fires 755 nm is a GentleMax, not a GentleYAG.

On a unit this age, buyers focus on the flashlamp hours or pulse count, the condition of the fiber and the handpiece window, whether the cooling device works, and whether a service company still supports it. Supply service records and the software version, list each delivery system and whether it has DCD, and photograph the model label and screen.