PICO-K

The PICO-K is an Nd:YAG laser surgical system for dermatological and aesthetic applications. It operates at 1064 nm and 532 nm wavelengths in picosecond mode for tattoo removal across all skin types, benign pigmented lesion removal, acne scar treatment, and wrinkle treatment. The system includes a power supply, laser resonator, LCD monitor, articulated arm, three interchangeable handpieces, and safety features such as key switch, interlock, and emergency stop.

The PICO-K employs two wavelengths (532 nm and 1064 nm) with picosecond pulse widths (300 ps), maximum repetition rates of 10 Hz, spot sizes ranging from 2–12 mm depending on handpiece type, and pulse energies up to 605 mJ (1064 nm) and 254 mJ (532 nm). It uses a patented resonator design with thermal lensing optimization. These parameters fall within the ranges of the predicate devices; notably, the subject device is a functional subset of predicates K202172 and K201773, lacking their Q-switched, long-pulse, and dye-handpiece modes.

Electrical safety and electromagnetic compatibility per IEC 60601-1 (v3.2, 2020), IEC 60601-1-2 (v4.1, 2020), and IEC 60601-2-22 (v4.0, 2019). Laser safety per IEC 60825-1 (v3.0, 2014). Biocompatibility per ISO 10993-5 (v3.0, 2009), ISO 10993-10 (v4.0, 2021), and ISO 10993-23 (v1.0, 2021). Software validation per FDA guidance on device software functions (June 2023). Bench testing of laser output energy, wavelength, repetition rate, spot size, pulse width, and beam output.

The PICO-K is substantially equivalent to predicates K202172 (StarWalker) and K201773 (PICOHI) because it has the same intended use in dermatological laser surgery and equivalent indications for tattoo removal and pigmented lesion treatment. The device's technological characteristics—dual wavelengths, picosecond pulse widths, and laser parameters—are within the ranges cleared for the predicates. As the subject device represents a functional subset of the predicates (lacking additional modes and handpiece types), it raises no new safety or effectiveness questions, and bench testing confirms claimed performance specifications.