CO2 Laser System (CO2 Laser SST-L23)

The CO2 Laser System (SST-L23) is a surgical laser device that uses electrically excited carbon dioxide gas to generate a focused laser beam for tissue vaporization and coagulation. It is indicated for use in dermatology, plastic surgery, general surgery, gynecology, podiatry, dental, and otorhinolaryngology procedures in hospital settings.

The device matches its predicate in maximum power (30W), wavelength (10.6 μm), work modes (single pulse, continuous, pulse), beam delivery (7-joint articulated arm), aiming beam (650nm red laser ≤5mW), and control interface (touch screen and footswitch). The main differences are appearance-related: the proposed device uses air cooling versus the predicate's water cooling, and has slightly different dimensions (39×45×117 cm vs 37.5×29×113 cm) and weight (44.83 kg vs 40 kg).

IEC 60601-1 (electrical safety), IEC 60601-2-22 (laser equipment safety), IEC 60825-1 (laser product safety), IEC 60601-1-2 (EMC), ISO 10993-5 (cytotoxicity), ISO 10993-10 (skin sensitization), and ISO 10993-23 (irritation). Non-clinical testing verified compliance with these standards.

The device is substantially equivalent because it shares identical intended use, regulatory classification (Class II, product code GEX), and all critical performance specifications (power, wavelength, modes, delivery system) with the predicate K200042. The differences in cooling system (air vs. water) and minor dimensional/weight variations are cosmetic and do not affect safety or effectiveness, as the device performs the same surgical functions through the same technological principles.