Red Light Beds
Full Body Red Light Therapy Beds
Research has shown that phototherapy can: increase circulation, accelerate tissue repair, decrease wrinkles, decrease inflammation, improve skin tone, texture and clarity, ease muscle and joint pain, stiffness, spasm and arthritis and kill acne bacteria, and much more.
Full Body Red Light Therapy has many General Wellness Intended Uses including:
|Improved muscle performance||Restoration of motion to joints||Redevelop muscles||Relaxation of muscles and relief from muscle spasms||Temporary relief of minor muscle and joint aches, pain and stiffness||Temporary relief of minor pain and stiffness associated with arthritis||To temporarily increase blood circulation||Adjunct to obesity as part of a diet and exercise program|
ACNE • ANTI-AGING • PAIN * ADJUNCT TO OBESITY
What is LED Light Therapy?
Light Emitting Diode (LED) phototherapy is the application of light energy to tissue to obtain therapeutic benefits. The energy is used to improve cellular performance. Phototherapy is known for its healing and anti-inflammatory properties and has a variety of applications across many medical fields.
Minimizes the appearance of fine lines and wrinkles
- Reduces the appearance of crow's feet
- Clears blemishes
- Improves the appearance of skin tone
- Regeneration/stimulation of collagen
- Restores skin's natural collagen activity
- Activates fibroblast cells which create collagen and elastin
- Helps the appearance of sun-damaged skin
- Creates more skin moisture which will help fill out skin
- Increases circulation, providing a healthier skin to
- Helps in reducing melanin production, which causes brown age spots
- Promotes nutritional elements existing within the skin
- Helps the appearance of irregular pigmentation
- Lessens skin coarseness
- Lessens pore size
- Stimulates and activates metabolic function in skin cells
- Smoothes texture
- Reduces skin degradation
- Reduces the appearance of overall redness and flushing
Red Light Beds are considered general wellness products and do not meet the definition of a device under section 201(h) of the FD&C Act and therefore are not subject to the FD&C Act’s regulatory requirements for devices. Meaning, they do NOT require FDA Clearance or 510(k) Clearance. Instead, these devices are simply "registered" with the FDA as General Wellness Products but can apply for a 510k clearance or other intended uses.
In JULY of 2015, the FDA has created a guidance document to describe their current thinking on the topic of Low Risk/General Wellness Devices. The document is called General Wellness: Policy for Low Risk Devices and can be found on the FDA.gov website. Please refer to that document for full details. The following is a brief overview.
The Center for Devices and Radiological Health defines general wellness products as products that meet the following two factors:
- intended for only general wellness use and
- present a very low risk to users’ safety
To be considered a general wellness product, a device has to have: an intended use that relates to a maintaining or encouraging a general state of health or a healthy activity
If the product’s intended uses are not limited to the above general wellness intended uses, this guidance does not apply. To be considered a LOW RISK device, the product cannot:
- be invasive
- involve an intervention or technology that may pose a risk to a user’s safety if device controls are not applied
- raise novel questions of usability
- raise questions of biocompatibility
Red Light Beds qualify as General Wellness Devices based on the criteria outlined, and is classified under FDA 21 CFR 890.5350, Exercise Component, product code IOD