CO2 Laser Therapy Systems (SHE-LSP003-1)

The CO2 Laser Therapy Systems (SHE-LSP003-1) is a laser surgical instrument used for body soft tissue ablation, vaporization, excision, and coagulation in dermatology, plastic surgery, and general surgery. It uses monochromatic CO2 laser light with strong penetration and precise focusing; when a continuous or pulsed laser beam irradiates biological tissue, the instantaneous high temperature causes photo-induced solidification and vaporization.

In normal mode, the device matches predicate K161925 in wavelength, laser type, laser classification, pulse width range, and frequency. In fractional mode, the device's parameters (density/spot range, pulse energy, spot size) fall within the range of predicate K241670, with a minor difference in pulse width range (0.1–9.9 ms versus 0.1–2.6 ms). The device operates at a fixed interval time of 1 ms regardless of emission frequency.

IEC 60601-1 (general medical device safety), IEC 60601-1-2 (electromagnetic compatibility), IEC 60601-2-22 (surgical laser equipment), IEC/TR 60601-4-2 (electromagnetic immunity guidance), IEC 60825-1 (laser product safety and classification), ISO 10993-5 (in vitro cytotoxicity), ISO 10993-10 (irritation and hypersensitivity), and ISO 10993-23 (irritation tests).

The applicant demonstrated substantial equivalence by showing the device meets identical technical specifications as K161925 in normal mode and operates within the parameter ranges of K241670 in fractional mode. All nonclinical testing confirmed compliance with applicable safety and performance standards, and the minor pulse width range difference does not affect actual safety or effectiveness. No clinical study was required because the device's performance matched the legally marketed predicate devices.