PICOALEX

The PICOALEX is an Alexandrite laser system indicated for tattoo and benign pigmented lesion removal, including Nevus of Ota, Hori macules, and Melasma. The device consists of a laser head with Alexandrite medium and xenon flash lamps, a power supply, cooling system, articulated delivery arm with handpiece, and software-controlled interface for treatment parameter selection.

The device operates at 755 nm wavelength with maximum 300 mJ ± 20% output power, pulse width of 600-800 picoseconds, repetition rate of 1-10 Hz, and adjustable spot sizes (Zoom: 2-8 mm ± 20%; MLA: 3.5-8 mm ± 20%). Maximum average fluence is 6.37 J/cm². The handpiece tip material is aluminum powder, contacting intact skin for limited duration (<24 hours).

IEC 60601-1:2005/(R)2012 and A1:2012 (medical electrical safety), IEC 60601-1-6 Edition 3.1 2013 (essential performance), IEC 60601-2-22:2007/A:2012 (particular laser requirements), IEC 60825-1 Edition 3.0 2014 (laser product safety and classification), IEC 60601-1-2:2014/A1:2020 (electromagnetic compatibility), and ISO 10993-1 (biocompatibility).

PICOALEX is substantially equivalent to the PicoSure predicate (K210226) because both are Alexandrite laser systems using identical 755 nm wavelength, same maximum output power (300 mJ ± 20%), same maximum fluence (6.37 J/cm²), identical repetition rates (1-10 Hz), and address the same intended uses for tattoo and benign pigmented lesion removal. The pulse width range (600-800 ps) is narrower but fully contained within the predicate's range (450-900 ps), and spot size differences do not raise safety concerns since larger spot sizes disperse energy more broadly.