Medical Picosecond ND: YAG Laser System (PZ-6)

The Medical Picosecond ND:YAG Laser System (PZ-6) is a multi-wavelength pulsed laser designed for surgical and aesthetic applications in dermatology, general surgery, and plastic surgery. It operates at 1064 nm and 532 nm wavelengths for tattoo removal across multiple skin types and treatment of benign pigmented lesions.

The device produces dual wavelengths (1064/532 nm) with pulse duration of 300–500 picoseconds, maximum pulse energy of 500 mJ (1064 nm) and 250 mJ (532 nm), adjustable spot size 2–10 mm, repetition rate 1–10 Hz, and maximum average fluence of 16 J/cm² (1064 nm) and 8 J/cm² (532 nm). It features an articulated arm with handpiece, LCD touchscreen display, foot-switch activation, and water circulation cooling.

IEC 60601-1:2005/AMD2:2020 (electrical safety), IEC 60601-1-2:2014+A1:2020 (electromagnetic compatibility), IEC 60601-2-22:2019 (laser equipment), IEC 60825-1:2014 (laser safety), ISO 10993-5:2009, ISO 10993-10:2021, and ISO 10993-23:2021 (biocompatibility).

The subject device operates on identical laser technology (Nd:YAG), produces the same dual wavelengths, pulse durations, and energy levels as the predicate, and shares identical intended uses for tattoo removal and benign pigmented lesion treatment across the same skin types. Non-clinical performance testing demonstrates compliance with the same consensus standards, and minor technological differences in specifications (e.g., spot size tolerances, cooling system design, electrical power specs) do not raise different questions of safety or effectiveness.