CO2 Laser Therapy System (Model: LFS-D9U)

The CO2 Laser Therapy System (Model: LFS-D9U) is a surgical laser device that uses a 10.6 µm infrared CO2 laser beam for human tissue vaporization and coagulation in dermatology, plastic surgery, and general surgery. The classical scanner mode is specifically indicated for treatment of wrinkles and skin resurfacing.

The device operates at 10.6 µm wavelength with maximum 30W output power, offering classical mode and surgical mode (continuous and repetitive pulses). Key specifications include 0.5mm spot size, 2.0×2.0mm to 20×20mm scan area, pulse energy of 1–300 mJ, pulse width of 1–10ms in classical mode and 1–500ms in normal mode, and 10–500Hz repetition rate.

The device complies with ANSI/AAMI ES60601-1:2005, IEC 60601-1-2 Edition 4.1, IEC 60601-2-22:2019, and IEC 60825-1:2014. Biocompatibility testing followed ISO 10993-5, ISO 10993-10, and ISO 10993-23. Software validation was performed per FDA guidance on device software functions.

The proposed device has the same intended use, similar indications for use, identical laser medium and wavelength, same 30W maximum power, and equivalent operating principles as the predicate device (K191518). Performance testing demonstrates the device meets expected specifications, and any differences in parameters (such as pulse width ranges) do not raise new safety or effectiveness concerns and remain within safe and effective windows established by predicate devices.