MateLaser Medical Diode Laser Systems (ML-DLS-30)

The MateLaser Medical Diode Laser Systems (ML-DLS-30) is a surgical laser device that emits 445nm, 970nm, and 660nm laser radiation for intra- and extra-oral surgery, dental procedures, teeth whitening, and low-level laser therapy. The device uses different laser diodes guided via quartz fibers to deliver laser energy for cutting, coagulation, tissue vaporization, and therapeutic heating.

The device operates in continuous wave (CW) and pulsed (ISP) modes with adjustable duty cycles. It features a home screen interface for configuring treatment parameters including wavelength selection, power settings, duty cycle, frequency, and treatment time. Key differences from the predicate include activation method and laser control unit dimensions, which are controlled within the scope of application and do not raise new safety or effectiveness concerns.

IEC 60601-1 (medical electrical equipment general safety), IEC 60601-1-2 (electromagnetic compatibility), IEC 60825-1 (laser safety equipment classification), IEC 60601-2-22 (surgical and therapeutic laser equipment), IEC 62304 (medical device software lifecycle), and ISO 10993-1 (biocompatibility testing for cytotoxicity, skin irritation, pyrogenicity, and acute systemic toxicity).

The MateLaser is substantially equivalent to the SIROLaser Blue predicate device because both share the same purpose, product code, regulation, laser classification, wavelengths, peak power specifications, optical fiber surgical tips, laser handpiece, control unit interface, usage modes, and electromagnetic/electrical safety compliance. Minor differences in activation method and control unit dimensions do not create new safety or effectiveness issues and are controlled within scope of application.