Q-Switched Nd:YAG Laser (SHE-LSP101-1)

The Q-Switched Nd:YAG Laser (SHE-LSP101-1) is a multi-wavelength pulsed laser system for dermatologic and general surgical procedures. It operates at 1064nm and 532nm wavelengths to treat tattoos (dark inks at 1064nm, light inks at 532nm), benign vascular lesions, and benign pigmented lesions through incision, excision, ablation, and vaporization of soft tissue.

The device produces two laser wavelengths (1064nm and 532nm, ±5nm tolerance) with adjustable spot sizes (3-8mm for 1064nm, 3-6mm for 532nm) and pulse energies (200-900mJ for 1064nm, 50-500mJ for 532nm). Maximum fluence is 12.74 J/cm² at 1064nm and 7.08 J/cm² at 532nm. The device includes a control panel, laser power module, temperature/humidity control, and cooling systems.

IEC 60601-1 Edition 3.2, IEC 60601-1-2 Edition 4.1, IEC 60601-2-22 Edition 3.1, IEC/TR 60601-4-2, IEC 60825-1 Edition 2.0, ISO 10993-5, ISO 10993-10, and ISO 10993-23. Non-clinical testing verified compliance with design specifications; clinical study was not required.

The device incorporates the intended uses of both primary predicate (PASTELLE Q-Switched Nd:YAG Laser, K123293) and secondary predicate (Medlite C6, K014234) devices with consolidated wavelength-specific treatment functions. It shares similar technological characteristics in wavelength, laser type, classification, pulse width, and spot size; minor differences in energy density fall within the predicate range and do not raise safety or effectiveness concerns. Non-clinical testing demonstrated compliance with applicable medical device standards.