A Trial of the Invisa-RED Elite's Effectiveness as a Therapy for Loss of Body Fat

The trial is designed to prove the efficacy and safety of the invisa-RED Technology Elite
Low-level Laser Therapy (LLLT) device. The trial will compare results between two groups; the
first will be treated using a fully functional invisa-RED Technology Elite device; this group
will be internally designated the Usual Care Group. The second, a control group, will be
treated utilizing a nonfunctional invisa-RED Technology Elite device; this group will be
referred to internally as the Sham Group.

The sham device will consist of an invisa-RED Technology Elite device that will appear to
operate as the Usual Care Group device to the operator, but the laser diodes will be disabled
and will receive no power. If staff or a participant questions the efficacy of the sham
device, an assertion may be made that only a near infrared, non-visible frequency of light,
is being employed.

The trial will be conducted employing a double blind study methodology; participants will be
randomly assigned to each group through a drawing, neither participants nor clinicians will
know to which trial group they are assigned. To ensure the double blind; treatment for the
two groups will occur separately using clinicians exclusive to each group.

A simplified weight loss protocol will be employed based on the "Consultation Protocol" from
the invisa-Red Training Manual. All study participants will undergo nine (9) therapy sessions
of 20 minutes each; power settings will be based on the participants Fitzpatrick Scale skin
type. For skin types i and ii a power setting of 7 will be used, for skin types iii and iv a
power setting of 6, for skin types v and vi a power setting of 4 will be employed. At the
conclusion of the nine (9) therapy sessions; the change in total body fat, body fat as a
percentage of total body weight, and inches lost of the two groups will be statistically
analyzed to determine the efficacy of the invisa-RED Technology Elite as a therapy to reduce
adipose tissue as a percentage of total body weight. Any medical errors will be included in
the statistical analysis.

Inclusion Criteria:

Any healthy individual.

Exclusion Criteria:

- If you are pregnant, trying to get pregnant or nursing laser light therapy should be
received only after the end of these conditions. There is no evidence of harm to a an
unborn baby however there have been no safety tests either, so for medical legal
reasons we recommend never treating areas directly over a developing child.

- Individuals with hypertension, light sensitive epilepsy, cancer, heart disease,
infectious skin disease, and severe varicose veins should not use this device.

- People suffering from infectious and acute disease such as a fever should not use this
device.

- People who have hemorrhagic disease, vascular ruptures, skin inflammation, or any
disease of the skin should not use this device.

- People who have immune system dysfunction such as Leukemia, Hemophilia, etc., and
light sensitive persons should not use this device.

- Individuals with a history of melanoma, raised moles, suspicious lesions, keloid scar
formation, or healing problems should not undergo laser light therapy.

- Individuals with active infections, open lesions, hives, herpetic lesions, cold sores,
or tattoos and permanent make-up in the area of treatment should not undergo laser
light therapy.

- People who have used isotretinoin (commonly known as Accutane), tetracycline, St.
John's Wort, or any photo sensitizing drugs in the last year should not undergo laser
light therapy.

- Individuals with autoimmune diseases such as Lupus, Scleroderma, or Vitiligo should
not undergo laser light therapy.

- Individuals who have pacemakers or other electro-stimulation devices surgically
implanted should not undergo laser light therapy.

- Any insulin dependent individual should consult their physician before undergoing
laser light therapy.

- All individuals considered "vulnerable" such as children, pregnant women, nursing home
residents or other institutionalized persons, students, employees, fetuses, prisoners,
and persons with decisional incapacity.