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The Importance of Diodes and Power Supply.

When using lasers for hair growth, power and wavelengths must be accurate and consistent.

Accuracy and consistency ensure optimal performance and better results.

Illumiflow is the standard for value-based laser technology, adhering to high-quality standards that ensure quality and consistency in power and output.

Illumiflow is also a pioneer for cost-effective technology that uses the proper laser wavelengths and has an unparalleled dedication to safety. Here are the key components to support these key claims:

 

 

  • Illumiflow has FDA Clearance for Class II Medical Device

 

Illumiflow meets FDA criteria to be classified and cleared as a class II medical device.  Other devices that meet this classification are wheelchairs and blood pressure cuffs.

Device classifications are regulated by the FDA and based on the intended use of the device as well as what the device's indications are (R1).

Classifications ensure that the proper steps have been taken with the FDA to ensure device safety and accountability. In order to establish FDA clearance, every product is subjected to rigorous testing and clinical trials. These classifications also measure the potential impact the device will have on health.

The FDA focuses on product performance, proper labeling, and data requirements (R2). The FDA continues to monitor the device even after it is placed on the market.

So what does this mean for Illumiflow?

Our company passed an on-site audit in 2018, so it has met all requirements from the FDA. The cliff notes version is that our product was found by the FDA to be safe, effective, and has the data to support these claims.

Here is some more information on our FDA clearance.

Illumiflow Uses High-Quality Premium Diodes

    A diode is also known as a laser and is the critical performer in laser cap technology. In order to get the desired results for hair growth, using premium diodes is essential.

    Laser caps use diodes as LLLT or low-level laser therapy to help customers restore their hair. Having low-quality lasers offers low-quality results.

    Illumiflow has dedicated our brand to providing affordable and premium grade technology to our customers- without cutting any corners.

    Currently, there are only a few suppliers that manufacture high-quality diodes (R3).

    Illumiflow uses one of those high-quality manufacturers as we source our Japanese-designed lasers from Taiwan.

    This high-quality is passed onto our customers, however the the extra cost is not. We have ensured that Illumiflow is an accessible and cost-effective option for our customers, without the high price tag.

    llumiflow Undergoes a Rigorous Quality Control Process

      Quality control is just one of the ways Illumiflow is the standard in comparison to other brands. Quality control is crucial because it guarantees that customers will receive a high-quality product, free from safety issues or defects.

      Illumiflow laser output is quality tested before assembly, after assembly, and then again before shipping to our customers.

      Quality control ensures that our customers receive a high-quality product with premium functioning and safety.

      Are Lasers Safe To Use For Regrowing Hair?

      Short answer: Yes!

      Longer answer:Illumiflow uses class 3R lasers to ensure our product works effectively but, most importantly, safety.

      Class 3R lasers are safe for use when compared to other laser classes. It is not necessary to use a higher-powered laser to ensure a quality product. In fact, anything more than 5mw is dangerous and not recommended for use in products like the Illumiflow laser caps.

      The FDA has found that the only way a 3R laser can be harmful is if someone stares directly at the light (R4). Using lasers higher than 5mw can cause potential health hazards to the skin and eyes (R4).

      We should also note that LEDs are not in the same category as laser technology.

      The FDA does not require LEDs to be subjected to the Federal laser product performance standard (R4). Sometimes laser caps use LED lasers in their products, but LED lasers do not provide the same level of effectiveness as 3R lasers.

      Illumiflow does not use LEDs in any of our products.

      What about Radiation?

      Illumiflows lasers will not cause radiation.

      Commonly, lasers are confused with the radiation from x-ray's or gamma rays (R6). Using Illumiflow is safe and cleared by the FDA.

      FDA classifications ensure where (and what for) lasers should be used and whether they are hazardous for health.

      Our lasers are Class 3R and safe for use. We should also note that laser radiation is not harmful and affects the body in a way that a basic light would (R5).

      Visible laser light radiation is simply deemed “light” vs other light sources on the spectrum (infrared or ultraviolet) emission is considered “radiation."

      Our product uses an inconsequential amount of EMF by using a closed battery for customer safety. Using a power source wired to the wall outlet increases EMF exposure significantly, so that was avoided in Illumiflow design.

      Power

      Illumiflow uses high-quality lasers to increase power output and ensure that the proper amount of energy is used on the scalp.

      There is a certain amount of energy per centimeter squared of the scalp for effectiveness, and low-quality lasers DO NOT meet this standard.

      Low quality lasers are ineffective and a waste of money they won’t emit power starting at 5mw. The lower amount of power would cause a negative effect on joules per cm/2 and render the laser useless.

      However, High-quality diodes mean nothing if the design does not support them correctly or if the battery is lacking. It is essential that consistent power is given to all diodes, or they will not be as effective.

      The design of Illumiflow was created to support equal power to all diodes. Research has found that optimal energy leads to an increase in the anagen phase hair follicle stimulation (R6).

      Diffused VS Undiffused Diodes

      When discussing power output, it is important to recognize the differences between diffused and undiffused diodes.

      Diffused diodes (or lasers) have full coverage and an equal depth to the skin surface. Undiffused lasers have a more localized reach that does not cover an even amount of the skin.

      Here is an excellent resource for photo reference.

      Undiffused lasers also have a "dot" effect, which causes less coverage of the skin and renders those laser ineffective to stimulate hair follicles evenly.

      The “cliff notes” version? No one wants random patches of hair growing on their head. Using diffused lasers creates the proper amount of laser coverage.

      This also makes a case for a diffused laser’s ability to maintain higher levels of energy required to get the desired effect.

      Think of diffused lasers as a pyramid that overlaps with their neighboring lasers to help maintain light density and proper placement of intersection.

      Wavelength

      Power and wavelength must be consistent in order for a laser cap to work effectively.

      The absorption rate and penetration levels for LLLT are best at levels close to 650 (red) nm with a 5mw per diode's peak performance.

      So why is this level perfect for laser cap technology? The answer lies in the absorption rate and reaction with the body.

      On a deeper level 650 (red) nm acts similar to a vitamin because its energy moves through the body and influences cells that have been damaged (R7).

      On a surface level, the majority of 650 (red) nm is absorbed more superficially, which is beneficial to stimulate the scalp, scar tissue, and of course, stimulating the cells responsible for hair growth (R8).

      More research on the effectiveness of 650 (red) nm shows that the laser light photons interact with cells by releasing energy that supports photobiostimulation (R8).

      Photobiostimulation is also known as LLLT or low-level laser therapy. Low-level laser therapy is the technology used by Illumiflow to regenerate cells and stimulate hair growth.

      Photobiostimulation is triggered by laser light and has three significant effects, an analgesic effect, tissue regeneration, and inflammatory action modulation.  An analgesic effect which reduces pain and inflammation (R8).

      Tissue regeneration is the healing of old, damaged tissue with the formation of new growth. The new growth restores old cells to a state of normal functioning (R9).  

      Lastly, Inflammatory action modulation is simply the mediation of inflammatory responses (R10).

      So what does all of this mean exactly? Low-level laser therapy can increase new cell growth, mediate inflammation, and reduce pain. When stimulating the cells for growth, LLLT effectively initiates cell regeneration, which causes hair to grow.

      For LLLT to work correctly, cytochrome C oxidase must absorb the laser light triggering photobiostimulation and, in turn, regeneration of cells.

      Numerous recent articles like, "Re-evaluation of the near-infrared spectra of mitochondrial cytochrome c oxidase: Implications for non-invasive in vivo monitoring of tissues" (Did you want to add this adam?) (G.Mason, P. Nicholls, E. Cooper – 2014 and  "Multiple Roles of Cytochrome c Oxidase in Mammalian Cells Under Action of Red and IR-A Radiation (T. Karu - 2010) demonstrated that 650 (red) nm light is most easily absorbed by cytochrome C oxidase, triggering photobiomodulation in the most effective way.

      Illumiflow was put to the test by Gamma Scientific, and its peak wavelengths measured at 649.8nm and 650.1nm well into the recommended levels perfectly.

      Pulse Vs. Continuous

      Some companies have switched to continuous use for marketing reasons (shorter, daily usage times may sound ‘easier’), but we continue to use pulsing lasers which have more historical documentation + adaption across other laser-using tissue healing applications.

      This choice made based on research that a pulse laser has more ability to regenerate in the “off” state to ensure that it has the maximum energy and laser power during its on state.

      Pulse provides balance and proper energy levels for maximum benefit. Studies have found that pulse light provides more safety because it offers the same energy with less increase to temperature (R11).  

      Summary

      Quality, performance, and safety are the driving forces for Illumiflow. Unfortunately, many companies do not want to pay the high cost of FDA clearance and high-quality lasers. It is important to research diligently to get the best quality product for hair growth goals.

      Illumiflow sets the standard for cost-effective LLLT technology and its applications. Products used for LLLT should be cleared by the FDA and able to withstand rigorous testing and quality control.

      Having the right design, power, wavelengths, and energy delivery is standard for getting the best results.

       

      References:

       

      R1: https://www.fda.gov/medical-devices/overview-device-regulation/classify-your-medical-device

       

      R2: https://www.qualio.com/blog/fda-medical-device-classes-differences

       

      R3: https://www.manufacturingtomorrow.com/story/2020/02/all-you-need-to-know-about-diode-lasers-and-laser-diodes/14731/

       

      R4: https://www.fda.gov/radiation-emitting-products/home-business-and-entertainment-products/laser-products-and-instruments

       

      R5: https://www.fda.gov/radiation-emitting-products/laser-products-and-instruments/frequently-asked-questions-about-lasers

       

      R6: https://link.springer.com/article/10.1007/s10103-018-02699-9

       

      R7: https://www.coldlasers.org/therapy/wavelength/

       

      R8: https://www.mectronicmedicale.com/en/news/why-is-the-650nm-red-light-so-efficient-4175

       

      R9: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3055648/

       

      R10: https://www.practicalpainmanagement.com/treatments/complementary/lasers/laser-accelerated-inflammation-pain-reduction-healing

       

      R11: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2933784/

       

       

       

       

       

       

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