modality intended to be operated by the patient for HOME CARE. The treatment modality of medical laser devices is commonly
called Low Level Laser Therapy (LLLT), photobiomodulation, or cold (non-thermal) laser therapy, when used for reducing pain and
inflammation, Parkinson’s and Fibromyalgia symptoms, as well as to promote tissue repair and recovery.
2.1 Operation description of laser treatment (general)
Treatment is performed by applying a generally optimal dose of laser energy in contact mode onto and around a condition, using a
point-by-point application procedure by holding the device in position, and switching application point at each signal. An audible and
visible signal informs the operator when to switch application point. At each signal, the laser aperture is moved approximately 1.5 cm
until the whole condition area has been covered. Treatment shall only be performed onto and in contact with intact normal skin and
skin conditions.
WARNING! Do NOT use the device in contact with sensitive and broken skin or open wounds. Do NOT use the device in
contact with eyelids. Do NOT view the divergent beam with magnifiers.
2.2 General risks and hazards with class 1 lasers (IEC60825-1:2014)
Laser products that are safe to use, still hold risks associated with misuse, such as long-term direct intra-beam viewing. Class 1 laser
products which emit visible radiant energy may still produce dazzling visual effects, particularly in low ambient light.
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