Q-Switched Nd: YAG Laser machine (LFS-C13U)

The Q-Switched Nd:YAG Laser machine (LFS-C13U) is a surgical laser system that delivers light at 1064nm or 532nm wavelengths for tattoo removal, treatment of benign vascular lesions, benign pigmented lesions, and soft tissue incision, excision, ablation, and vaporization in dermatology and general surgery. The device comprises a main unit, articulated light guide arm, and footswitch, weighing ≤100kg.

The device uses an Nd:YAG laser with dual wavelengths (1064nm and 532nm), spot size of 2–10mm, pulse width of 4–16ns, Q-switched pulse output, repetition rate of 1–10Hz, and internal distilled water cooling. Maximum pulse energy is 800mJ at 1064nm and 250mJ at 532nm. It includes an aiming beam at 630–670nm (≤1mW) and operates at 110VAC 60Hz or 230VAC 50Hz.

The device complies with ANSI/AAMI ES60601-1:2005 and amendments, IEC 60601-1-2 Edition 4.1 (electromagnetic compatibility), IEC 60601-2-22:2019 (surgical laser equipment), IEC 60825-1:2014 (laser safety), and biocompatibility testing per ISO 10993-5, ISO 10993-10, and ISO 10993-23.

The device has the same intended use, similar indications for use, identical technological characteristics (Nd:YAG dual wavelength, Q-switched pulse), and same operating principles as predicate devices K193609 and K173038. Minor differences in maximum output power and aiming beam parameters do not raise new safety or effectiveness issues. Non-clinical testing demonstrates compliance with applicable safety and performance standards, establishing substantial equivalence.