Fraxel Dual

Fraxel DUAL is Solta Medical's fractional laser that combines a 1550 nm source and a 1927 nm source in one console. A fiber feeds a handpiece whose scanning optics place a pattern of thermal zones in the skin. The line started as the Fraxel re:store, cleared in October 2009 under K091420, and the re:store Dual name appears in FDA's September 2010 clearance, K101490, for model MC-SYS-SR1500-D-US. A June 2013 clearance, K130193, named the system Fraxel DUAL 1550/1927 and broadened the 1927 nm indications.

Under those clearances, the 1550 nm wavelength is used for soft tissue coagulation, skin resurfacing, dyschromia, lentigos, actinic keratosis, melasma, periorbital wrinkles, acne scars and surgical scars. The 1927 nm wavelength covers soft tissue coagulation, actinic keratosis and pigmented lesions such as lentigos and freckles. FDA lists tip kits and a pre treatment solution as accessories, and its device database lists large roller tips, small extended roller tips, a cool roller tip and a handpiece cooling adapter under the SR1500 platform.

Several Fraxel models share the brand, so check the label. The re:store has the 1550 nm source alone, while re:pair is a separate system that FDA lists as the Fraxel III SR. The newest is Fraxel FTX, cleared in August 2024 with the same two wavelengths. FDA's device database describes FTX as the next generation console and lists single use 7 mm and 15 mm tips in packs, one with an authenticator, so a system that takes those tips is an FTX rather than a DUAL.

For a DUAL, read the model number from the rear label. Refurbished domestic units carry an R at the end. A buyer will ask for any usage or treatment counts the screen shows, the software version and when the laser sources were last serviced. List the handpiece, the roller tips and the cooling adapter with their condition. Photos of the label, the startup screen and the tips help a dealer make an offer.