CO2 Laser Machine (Lume)

The CO2 Laser Machine (Lume) is a surgical laser device that generates a 10,600 nm wavelength beam to vaporize and coagulate soft tissue. It is used in dermatology, plastic surgery, general surgery, and gynecology for tissue ablation, hemostasis, and skin rejuvenation through fibroblast stimulation and collagen formation.

The device uses an RF tube CO2 laser with 10,600 nm wavelength, output power of 1–30 W, pulse durations of 1–100 ms, and a 300 μm spot size. It features an articulated arm delivery system, LCD touchscreen interface, foot-switch control, fractional and normal operation modes, and Class IV laser classification. Key differences from predicates include variations in aiming beam power, pulse energy ranges, spot size, and scan area size, but these fall within or closely overlap predicate device ranges.

ISO 10993-5:2009 (in vitro cytotoxicity), ISO 10993-10:2021 (skin sensitization), ISO 10993-23:2021 (irritation), ANSI AAMI ES60601-1:2005 & A1:2012 & A2:2021 (medical electrical equipment safety), IEC 60601-1-2:2014+A1:2020 (electromagnetic disturbances), IEC 60601-2-22:2019 (surgical laser equipment safety), and IEC 60825-1:2014 (laser product classification).

The proposed device shares the same intended use (soft tissue vaporization and coagulation across multiple surgical specialties) and laser wavelength (10,600 nm) with two predicate devices. Although operational and performance parameters differ (e.g., pulse duration, spot size, output power), the differences are non-material because they either fall within predicate ranges, are covered by overlapping ranges across both predicates, or do not raise new safety or efficacy concerns. Biocompatibility and electrical safety testing demonstrated that these variations pose no new safety issues.