CO2 Laser Machine (Monica-I,Monica-II)

The CO2 Laser Machine (Monica-I and Monica-II models) 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 to treat skin lesions and perform cosmetic procedures through tissue ablation and hemostasis.

The device uses an RF tube CO2 laser with articulated arm delivery, foot switch emission control, LCD touch screen interface, and fractional and normal operating modes (CW, Single, Repetitive, Ultra pulse). Key parameters include 1-30W output power, 3-300 mJ/dot fractional pulse energy, 0.1-10 ms fractional pulse duration, 150 μm spot size, and 1x1 mm to 20x20 mm scan area. Minor differences from predicate include aiming beam wavelength (635 nm vs. 650 nm) and slightly narrower ranges in output power, pulse energy, and spot density.

ANSI AAMI ES60601-1:2005, IEC 60601-1-2:2014+A1:2020, IEC 60601-2-22:2019, IEC 60825-1:2014, ISO 10993-5:2009, ISO 10993-10:2021, and ISO 10993-23:2021.

The proposed device has the same intended use, laser type, wavelength, and delivery mechanism as the predicate device (CO2 Laser Therapy System HS-411, K201109). All identified technological differences—including aiming beam power/wavelength, output power range, pulse parameters, and scan area size—are either minor spectral shifts or fall within predicate ranges, and do not raise new safety or effectiveness concerns. Non-clinical testing demonstrates the device meets applicable electrical and biocompatibility standards.