Fractional CO2 Laser Therapy System (FG900-S); Fractional CO2 Laser Therapy System (FG900-S2)

The Fractional CO2 Laser Therapy System (FG900-S and FG900-S2) is a medical laser device used for soft tissue ablation, vaporization, excision, and coagulation in dermatology, plastic surgery, and general surgery. It consists of a main unit, articulated arm with treatment head, foot switch, and protective goggles, and operates in both fractional and normal modes to treat skin lesions.

The proposed device uses a 10.6 μm CO2 laser with maximum 35W output power, matching the predicate device. Key differences include: aiming beam power of max 5mW (versus <2mW in predicate), electrical requirements of 230V 50/60Hz (versus 110-240VAC in predicate), and slightly different pulse mode nomenclature (Continuous/Single/Repetitive versus CW/Single/Pulse/S-pulse/U-pulse), though parameters remain comparable.

IEC 60601-1:2020 (electrical safety), IEC 60825-1:2014 (laser safety), IEC 60601-2-22:2012 (surgical laser equipment), IEC 60601-1-2:2020 (EMC), ISO 10993-5:2009 (cytotoxicity), ISO 10993-10:2021 (skin sensitization), and ISO 10993-23:2021 (irritation).

The proposed device is substantially equivalent because it shares identical laser wavelength (10.6 μm), medium (CO2), maximum power (35W), pulse energy range (1-300mJ/dot), spot size (0.12mm), scan area (2x2-20x20mm), and beam delivery method (articulated arm) with the predicate K221597. Minor differences in aiming beam power, electrical voltage range, and pulse mode naming do not affect safety or effectiveness because testing confirmed the device operates normally under these specifications and the aiming beam poses no thermal hazard. The operational modes, though named differently, provide comparable parameters across fractional and normal modes.