CO2 Laser System

The CO2 Laser System is a surgical laser device used for tissue vaporization and coagulation across multiple medical specialties including dermatology, plastic surgery, general surgery, gynecology, podiatry, dental, and otorhinolaryngology. It operates at a wavelength of 10.6 micrometers with a maximum power of 30W and uses an articulated arm with seven joints for beam delivery.

The subject device (GL066) has identical key specifications to the predicate device (SL-LC01): 30W maximum power, 10.6 μm wavelength, 0.5mm spot size, 1-1000ms pulse duration, and three work modes (single pulse, continuous, pulse). The primary difference is in cooling system design—the subject device uses air cooling while the predicate uses closed-loop water cooling—and minor differences in physical dimensions (64x51x122cm vs 37.5x29x113cm) and weight (65kg vs 40kg).

The device was tested against IEC 60601-1:2020 (general electrical safety), IEC 60601-1-2:2020 (electromagnetic compatibility), IEC 60601-2-22:2019 (laser equipment safety), IEC 60825-1:2014 (laser product safety), ISO 10993-5:2009 (cytotoxicity), ISO 10993-10:2021 (skin sensitization), and ISO 10993-23:2021 (irritation).

The subject device is substantially equivalent because it has identical indications for use, classification, product code, maximum power, wavelength, beam delivery system, output modes, pulse duration, control mechanisms, and laser medium as the predicate device. Although the cooling system differs (air vs. water) and physical dimensions vary, the manufacturer argues these differences do not affect safety or effectiveness. Nonclinical testing demonstrates equivalent biocompatibility and electromagnetic safety performance.