1. What is a General Wellness Device?
On September 27, 2019, the FDA issued a guidance document titled “General Wellness: Policy for Low Risk Devices.” This policy defines general wellness products as products that meet two factors: (1 ) they are intended for only general wellness use and (2) they present a low risk to safety of users and other persons. A general wellness product, for the purposes of this guidance, has (1) an intended use that relates to maintaining or encouraging a general state of health or a healthy activity, or (2) an intended use that relates the role of healthy lifestyle with helping to reduce the risk or impact of certain chronic diseases or conditions and where it is well understood and accepted that healthy lifestyle choices may play an important role in health outcomes for the disease or condition. To read the complete policy, you can download it from the FDA website here.
purposes of this guidance, has (1) an intended use that relates to maintaining or encouraging a general state of health or a healthy activity, or (2) an intended use that relates the role of healthy lifestyle with helping to reduce the risk or impact of certain chronic diseases or conditions and where it is well understood and accepted that healthy lifestyle choices may play an important role in health outcomes for the disease or condition. To read the complete policy, please visit the FDA website.
2. What does Comprehensive Healing mean?
By definition, “comprehensive” is an adjective meaning to cover or involve all or nearly all elements or aspects of something. As opposed to single-use light therapy devices, the Visum Light device is your one go-to therapy device with user-controlled functions and multiple wavelengths for comprehensive healing.
3. How can the Visum Light benefit my practice?
Visum Light uses the power of LED light therapy to effectively assist your patients by:
- reducing pain of musculoskeletal disorders
- reducing inflammation both locally and systemically
- accelerating the natural healing process
- enhancing collagen production
This helps you to help your patients:
- get pain relief
- heal quicker
- feel better
- look better
Light therapy is scientifically proven to be both effective and safe. Delivering light therapy using the Visum Light device means your practice will have: happy, satisfied customers that will refer you an enjoyable customer experience ensuring repeat visits provided value for money a great return on investment .
4. How can the Visum Light improve my Health?
Do you suffer from pain, high blood pressure, recent surgery recovery, arthritis, or just general age-related issues? Research has shown that LED light therapy has significant anti-inflammatory effects in the body, both locally where the light is applied and systemically in other tissues and organs. Reducing inflammation is particularly important for disorders of the joints, traumatic injuries and lung disorders. LED light therapy has also been shown to be an effective treatment in reducing pain in patients with musculoskeletal disorders, accelerating healing and protecting against scar formation.
5. How can the Visum Light improve my Wellness?
In conjunction with a healthy lifestyle, the Visum Light device can help maintain a healthy weight, improve athletic performance, relieve exercise-related muscle pain, improve sleep cycles and increase mental acuity.
6. How can the Visum Light improve my Self-esteem?
LED phototherapy (also known as light therapy) has been shown to be beneficial in a large range of medical and cosmetic uses including skin rejuvenation. With continued use, light therapy improves skin tone and texture as well as encouraging the natural healing process. Visum Light uses LED light to stimulate cellular energy known as ATP (adenosine triphosphate). ATP is the cell’s energy source and provides the energy needed for the body to heal itself. Cells known as fibroblasts are responsible for producing collagen, and by stimulating the production of ATP in fibroblasts, collagen production is enhanced. Collagen is a protein found in the skin. Healthy collagen levels are responsible for firm skin, strong nails, and glossy hair. As we age, the body produces less collagen, which is why the skin shows signs of aging, such as wrinkles and age spots. In addition, low levels of collagen can also cause inflammation, which is why light therapy helps with inflammatory skin conditions such as eczema and psoriasis.
7. How will the Visum Light work for you?
Visum Light is the new LED General Wellness Light Therapy Device from Photonic Healing LLC. LED phototherapy (also known as light therapy), when used in conjunction with a healthy lifestyle, has been shown to be beneficial in a large range of medical and cosmetic uses such as pain relief, wound healing and skin rejuvenation. With continued use, light therapy accelerates the natural healing process and improves skin tone and texture. Light therapy works at the cellular level, stimulating cellular energy known as ATP (adenosine triphosphate). ATP is the cell’s energy source and provides the energy needed for the body to heal itself. Cells known as fibroblasts are responsible for producing collagen, and by stimulating the production of ATP in fibroblasts, collagen production is enhanced. Collagen is a protein found in the skin and other connective tissues. Healthy collagen levels are responsible for firm skin, strong nails, dense bones, and healthy muscles, joints and tendons. As we age, the body produces less collagen, which is why the skin shows signs of aging (wrinkles / age spots). In addition, low levels of collagen can also cause inflammation, soreness and stiffness, which is why light therapy helps with inflammatory skin conditions, wound healing and arthritis.
8. What are the differences between Visum Light device and other medical grade red light therapy devices?
The Visum Light device is unlike any other light therapy device currently available. Offering maximum flexibility with 4 operating modes and multiple color combinations, the Visum Light device is setting a new industry standard for comprehensive healing devices. With user-controlled functions and timer, the healing options are unlimited. You’re not stuck with one pattern or set timer, as in other devices. You, the user, can control each treatment to target the specific aliments and conditions you’re focused on. The Visum Light device is effective for all these situations:
- Acute/chronic injuries
- Arthritis/joint pain
- Back pain
- Behaviors: fear, aggression, anxiety, depression
- Colic/digestion issues
- Viral infections
- Muscle strains & soreness
- Tendon/ligament injuries
- Cuts and open wounds
- Immune system disorders
- Body soreness
- Lameness/laminitis knees, ankles and all joints
- And much, much more!
9. What are the colors of the Visum Light and why are they Beneficial?
The Visum Light device harnesses the healing power of red, near-infrared (NIR), blue, green, magenta, turquoise, yellow, and white light at specific wavelengths and frequencies shown to be effective in:
- lowering pain
- increasing circulation
- stimulating cellular repair
- accelerating natural healing
- reducing swelling and inflammation
Cells that are injured can actually be rejuvenated by light. The visible red and invisible infrared portions of the spectrum have been shown to have highly absorbent and unique therapeutic effects in living tissues.
For a complete explanation of the colors in the Visum Light device, please read here.
10. What are the Operating Modes of the Visum Light and how do I use them?
The Visum Light device has four operating modes which allow the user the ability and flexibility to target treatment most effectively:
- Continuous mode — allows the user to control the color combination and duration
- Direct Dosing mode — the user controls the Joules delivered by adjusting the power intensity and time, after selecting the desired color combination. For a more detailed explanation of Direct Dosing, please read here.
- Pre-programmed Patterns — the user selects the appropriate healing pattern, color combination and time. For a more detailed explanation of the Pre-programmed Patterns, please read here.
- Nogier Frequencies — the user selects the desired frequency, color combination and time. For a more detailed explanation of the Nogier Frequencies, please read here.
11. Are there any scientific studies to back up medical grade red light therapy, blue light therapy, and green light therapy?
Danish physicist Niels Finsen won the Nobel Prize in Medicine in 1903 for his work using light therapy to treat infections, but it wasn’t until the 1960s that modern study on light therapy really began. In the late 1980s, NASA started experimenting with light therapy using LEDs and found a 40% improvement in musculoskeletal injuries and a 50% faster healing rate in wounds when light therapy was used. It’s generally accepted that LED light therapy has an anti-inflammatory effect and has been shown to significantly reduce both acute and chronic pain in professional athletes. Within the field of dermatology, advances in the use of LEDs have led to their more mainstream use in a wide range of medical and aesthetic conditions. In 2011, a literature review published in the Journal of Laser Surgery, Phototherapy and Photobioactivation concluded that LED phototherapy works and is effective in a large variety of clinical applications, including wound healing, skin rejuvenation and pain relief.
12. Is light therapy safe?
LED light therapy is a non-invasive and non-thermal procedure which uses varying wavelengths of light to trigger the body’s natural healing process. It doesn’t contain UV rays, which can be harmful to the skin, and unlike chemical or laser therapy, LED light therapy does not cause burns. In fact, one of the main benefits of LED light therapy is its safety record. Research published in the Journal of Clinical and Aesthetic Dermatology in 2018 concluded not only that phototherapy using LEDs is beneficial for a range of medical and aesthetic conditions, but that it also displays an excellent safety profile.
13. What are the Side Effects of Medical grade red light therapy?
Light therapy is a completely natural process that exposes skin to low levels of light that, unlike the UV light from the sun, are not harmful. Because of this, there is a very low risk of side effects. Research has concluded that not only is light therapy effective, but it also has an excellent safety profile. The Visum Light device is designed to deliver safe and effective dosing in all of its operating modes. As the Visum Light device offers multiple power settings in one light, care should be taken when applying the light around the eyes on the higher settings. Never look directly into a bright light. And as with any device, be certain to read all instructions before using the Visum Light device.
14. What is the difference between LEDs and Lasers?
Laser therapy is often confused with light therapy. Both lasers and LEDs are capable of producing healing light at the correct wavelengths, but they differ in the way the light is delivered. The laser is coherent light (all of the wavelengths go together in a beam), and the LED is a non-coherent light (the wavelengths are diffused and cover a wider area). Studies show that the body can produce coherent light from non-coherent light, particularly when used over certain areas such as acupoints. This means the cell can actually be in control of the treatment and shut off the molecules when it is done. With the laser, the cells are no longer in control. The doctor or the practitioner applying the laser is in control. Laser light is invasive and LED light is non-invasive. If a laser is applied too long or with too much strength, it can cause tissue damage. Lasers also emit radiation. Because of these considerations, most lasers are used in the medical field, where practitioners not only know and understand the body, but have also received extensive training. Research has demonstrated that light therapy is as effective as laser therapy, but safer and with better outcomes.
15. How do I apply the Visum Light device to get the best results?
Please read the contraindications and safety precautions in the FAQ before you start using the Visum Light device.
- Press and hold the power button. You will hear three beeps.
- Select the color combination and the operating mode you will be using.
- Adjust the timer as desired.
- Press the power button once and the cycle will start.
- Place the light as close to the skin as possible on the area to be treated.
Keep the light in position until the unit beeps again. At the end of the cycle, the Visum Light device will be in standby mode before switching off automatically. While in standby mode, move the light to the next area, select your colors and operating mode, adjust the timer as desired, and press the power button again. Repeat these steps until the entire problem area has been addressed. Holding the light against the skin ensures maximum penetration depth. If you’re treating larger joints like the knees or elbows, the Visum Light can be applied to the whole circumference of the joint. Most people using the Visum Light will start to feel the benefits straight away, but it can take a couple of days to feel the full effect. And for chronic pain, you may need to treat 2-3 times per day. The body doesn’t build up resistance to low level light therapy, so treatments can be ongoing. However, if the pain persists or remains severe, please consult your medical professional.
16. How do I Clean the Visum Light device?
- Clean the Visum Light device before and after application
- Use an alcohol wipe and go over the entire surface
- Sanitize the silicone tray before returning the light for storage.
- Never immerse or clean the unit with water. If the unit gets wet, use the dry cloth provided to remove any moisture
- Clean the skin before application of treatment – make-up, cosmetics or debris may block the light.
The Visum Light device should always be stored in a safe, dry area, away from direct light or extreme heat and preferably within the carry bag provided. Care should be taken when working with the device to avoid accidental dropping.
17. What are the Contraindications and Safety Precautions?
Whilst low level light therapy (LLLT) has been shown to be both effective and safe, the Visum Light device is not intended as a replacement for standard medical procedures, medication or treatment. Always consult your medical professional if you have an underlying health condition, and do not discontinue the use of any medications or rely solely on the Visum Light device for your complete medical care. Not all conditions will benefit from LLLT in the same way. In particular, you should seek medical advice before using LLLT if you:
- are using anti-inflammatory or steroid/cortisone medications, as this may reduce the effectiveness of light therapy.
- have epilepsy — some studies suggest seizures can be induced with light frequencies in the 5-10 Hz range.
- have pancreatitis or insulin-dependent Type I diabetes — your insulin levels will need monitoring, as LLLT can cause the pancreas to produce insulin.
- are pregnant — this device is not approved for use in pregnancy. And some acupoints can induce labor.
- have cancer or a suspected cancerous mass — for professionals, be sure to check your state laws for specific regulations, as they vary from state to state.
- If you have a chronic condition, you may initially experience some slight discomfort. This is not a cause for concern, and treatment can be continued.
- Eye protection is not required, although protective glasses designed for those with bright light sensitivity may be desired. Do not look directly into the emitted light.
- The Visum Light device is not sterile, so avoid contact with broken skin, as it may cause infection.
- Do not treat areas of the body near a pacemaker.
- Stop use immediately if you become lightheaded. Check that you are using the device as directed. If the symptoms persist, consult a medical professional.
- Do not use any LLLT device while under the influence of drugs or alcohol.
- Do not use in conjunction with any heat-producing products, such as salves or ointments, as this may cause burning.
- If the device becomes hot, or the heat causes any discomfort, stop use and turn it off immediately.
- The electronics may be damaged when exposed to water, so only use on clean, dry skin.
- Avoid using the Visum Light device where it may come into contact with water, as this could result in electric shock.
- Avoid putting heavy objects on top of the device. This may damage it.
- Do not store the Visum Light device near a sink, bath, toilet or anywhere it could come into contact with water, as the device is not waterproof.
Please read the user guidelines and treatment protocols carefully. The manufacturers and distributors of the Visum Light device can in no way be held responsible for any damage, losses or injuries incurred from use outside of these guidelines and protocols. Photonic Healing LLC, dba Visum Light, make no warranties, expressed or implied, as to the use or effectiveness of our products for a particular purpose. The products represented have not been cleared by the FDA for marketing purposes. The information provided is for informational purposes only and is never intended to be a substitute for advice from your medical health care professional, nor is this a substitute for veterinary medicine.
18. What comes with my order and what is your Warranty and Return Policy?
In addition to your Visum Light device, you will receive:
- Quick Start Guide
- User Manual
- AC adaptor plug (use this plug only to charge the light)
- USB cable (use this cable only to charge the light)
- silicone storage tray
- cleaning cloth
- storage/carrying case
- 1-year manufacturer’s warranty
- 45-day money-back guarantee
- 30-minute Q&A with a Visum Light Specialist
19. Am I able to use the light while is is charging?
The Visum Light is not designed to be operated while it is being charged. Please disconnect the charging cable prior to use.
If you ever have questions about the Visum Light device, technical support is just an email away. Contact us here. This is a risk-free decision!