RSR-000886-000 (1)
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3. Device Description
The laser systems include a therapeutic laser console and optical delivery system. The
optical delivery system consists of a flexible optical fiber connected to a hand piece with
interchangeable treatment heads. A custom software application allows the user to select
from built-in treatment protocols that adjust dosage and wavelength based on the patient's
characteristics and condition. The device also provides the ability to set custom treatment
parameters including output power, treatment time, and pulse rate. Once the user has
selected the desired treatment parameters, activation of laser emission requires that the
operator follow a sequence of predetermined steps.
3.1. Indications for Use
810 nm and 980 nm wavelength:
The laser system emits energy in the visible and near-infrared spectrum to provide
topical heating for the purpose of elevating tissue temperature for a temporary relief
of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm;
the temporary increase in local blood circulation; the temporary relaxation of muscle.
The device is meant for professional use only by licensed practitioners.
Caution:
Federal, national, or local laws may restrict this device to sale by or on the
order of a licensed practitioner licensed by the applicable authorities to use and/or
prescribe use.
3.2. Contraindications
•
Do not apply infrared light to abdominal or lumbosacral points in pregnant females.
•
Do not apply infrared light to the epiphyseal lines in children.
•
Do not apply infrared light to the thoracic region or over the pacemaker itself in
patients with pacemakers.
•
Do not apply infrared light over the thyroid gland, ovaries or testicles.
•
Do not apply infrared light to patients who are taking drugs that have heat or light
sensitive contraindications, such as but not limited to certain types of steroids.
3.3. Maximum Permissible Exposure (MPE)
Maximum Permissible Exposure (MPE) is the highest power density (in W/m
2
) from a light
source that does not require clinical evidence to be considered safe. For the laser radiation
from the laser system, the MPE for ocular and skin exposure is determined by the
wavelength, beam divergence, and exposure time. For times between 10 and 3000 seconds,
the ocular MPE is 418.9 W/m
2
and the skin MPE is 3027.1 W/m
2
.
