Candela Smoothbeam

The Candela Smoothbeam is a 1450 nm diode laser for dermatology, paired with Candela's Dynamic Cooling Device. Its first FDA clearance, K002421 in November 2000, was filed as the Candela Mid IR Diode Laser System, and a 2003 Candela summary confirms that this is the same device later sold as Smoothbeam. The Smoothbeam name appears on a clearance for periorbital wrinkles in February 2002 (K013825). Candela then added back acne in October 2002 (K014128), atrophic acne scars in January 2003 (K022884), facial wrinkles in September 2003 (K030846), mild to moderate inflammatory acne vulgaris in December 2003 (K030834), and sebaceous hyperplasia in November 2004 (K041242).

The summaries describe the system as a power supply, an optical delivery system, software control and the Dynamic Cooling Device. Laser output travels through an optical fiber to a handpiece that produces a circular spot, and cryogen from a cooling device integrated into the laser is sprayed through a hose to a nozzle in the handpiece in short bursts during the pulse. A 2006 acne study run with a Candela Smoothbeam used a 6 mm spot, 210 ms pulses and 12.5 J/cm2 with dynamic cooling.

A search of FDA's GUDID database returns no Smoothbeam entries, so part numbers will not help here. The wavelength is the simplest check: Smoothbeam is Candela's 1450 nm system, while its GentleLase and GentleYAG lasers of the same era run at 755 nm and 1064 nm, and the label and clearance history do the rest.

For a laser of this age, the first question is service: whether the diode module still meets its rated output, and whether a technician who knows the platform has worked on it recently. Buyers will also ask about the fiber and handpiece, whether the cooling device sprays evenly, the cryogen canister, and any error history. Provide service records, and photograph the serial label, the control panel at power on, and the handpiece.