Acclaro UltraClear

UltraClear is a fractional fiber laser at 2910 nm made by Acclaro, which calls it a cold fiber laser platform. FDA's first clearance, K210847 in December 2021, went to FA International of Rhode Island for the UltraClear Laser System. That summary describes laser diodes pumping an erbium doped fluoride glass fiber to produce 2910 nm light, delivered through a fiber optic arm and handpiece with a 635 nm red aiming beam. Acclaro Corporation received a second clearance, K233803, in May 2024 for the UltraClear Fractional Laser System, citing the Sciton Joule ProFractional as predicate and the 2021 system as reference.

The console is transportable, with a 15 inch touch screen, foot pedal, emergency stop, remote interlock and a calibration port. Inside are the laser module, scanner drivers, a thermoelectric cooling module and a water pump. The 2024 summary gives 10 W of laser power, a 170 micron microbeam, spot sizes from 2 x 2 mm to 15 x 15 mm, repetition up to 3 Hz, pulse durations of 0.1 to 3.0 ms and no skin cooling. It lists Clear mode at 0.6 to 1.5 mJ per microbeam, Silk mode at 1.5 to 3.0 mJ, Ultra mode at 3.6 to 30 mJ, and a combined UltraClear mode.

Acclaro's site lists seven treatment modules on the one device: Clear, Clear+, Ultra, UltraClear, Laser-Coring and Laser-Coring Elite, Full Ablation and Surgical, along with its 3DIntelliPulse pulse technology. FDA's device identifier database lists the console as a fractional mid IR fiber laser system in several colors, including white, black, purple metallic and blue metallic, under catalog numbers ending in 00055.

When selling an UltraClear, give the applicant name on the label, the console color and model number, the software version and the modules available on screen. Buyers will check the fiber arm, the handpiece optics, results from the calibration port and the service history. Photograph the serial label and the main screen.