Q-Switched Nd: YAG Laser Systems

The Q-Switched Nd:YAG Laser System (HS-290, HS-290E) is a surgical laser intended for dermatological applications including tattoo removal, treatment of benign vascular and pigmented lesions, hair removal, and skin resurfacing. It operates at 532nm and 1064nm wavelengths in multiple modes (Q-switched, SPT, and long-pulse) with various handpieces to deliver coherent light pulses to target tissue.

The device produces wavelengths of 532nm and 1064nm with maximum output energies ranging from 240–1400mJ depending on mode and handpiece. Pulse durations range from 4–6ns (Q-switched), 300ps (SPT), and 5–150ms (long-pulse), with repetition rates up to 10Hz and spot sizes from 2–10mm. These specifications match or fall within the ranges of three predicate devices (K190936, K213569, K202288).

The device was tested for compliance with IEC 60601-1:2005+A1:2012+A2:2020 (medical electrical equipment general safety), IEC 60601-1-2:2014+A1:2020 (electromagnetic compatibility), IEC 60601-2-22:2019 (surgical laser equipment), and IEC 60825-1:2014 (laser product safety and classification).

The subject device is substantially equivalent because its wavelengths, output energies, pulse durations, repetition rates, and spot sizes are either identical to or minor variants of three legally marketed predicate devices, with the same indications for use and no new safety or effectiveness concerns identified in non-clinical testing.