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Recently at the ISHRS (International Society of Hair Restoration Surgeons) Annual Conference held in Las Vegas 2007, a comparison was made between the Sunetics Laser Hair Brush and another leading hand-held product. This comparison was made without the understanding of the design and inherent safety consideration for a home use product.
Modern lasers are semiconductor based as opposed to the large, gas based lasers of the 1960s to 1990s. In today’s lasers, there is a diode which generates the laser energy. Natively, this laser in its simplest form requires the use of a collimation, or focusing lens. This lens is what takes the naturally divergent laser energy and puts it into what the average person would recognize as a "laser beam". Any laser product today from a simple laser pointer to a laser show at a concert uses these same components.
In the United States, the CDRH (Center for Devices and Radiological Health) and Internationally the IEC (International Electro technical Commission) set the standards for laser safety. While the standards are somewhat different, they generally agree on the key points.
The laser hair products today generally available to the public use, nominally, lasers that generate a maximum of 4.9mw per module. For example, if a product has multiple laser modules, any individual one cannot exceed this limit and still be considered by USA and International regulations a product that can be sold to the general public. Even the more extensive hooded systems which have 30-80 lasers or more face the same requirement.
Further, the FDA (Food and Drug Administration) has rallied against children’s use of even simple laser pointers due to safety considerations. A number of countries now restrict the maximum power level available to the public and many States restrict the purchase of laser pointers to adults.
Manufacturers in the "hooded" hair laser manufacturing arena have long recognized the potential for a patient to look up into the laser treatment unit. Through the years they have designed into them interlocks and cutoff sensors that turned off the lasers if the patient moved their head in such a way as to accidentally view the lasers themselves.
The danger here is that these units universally use collimated, or focused, laser beams which concentrate the total energy of each laser diode into a very small dot which can be easily focused into the eye and the retina of a non-laser educated person.
The current generation of the laser brush and laser comb products also use collimated or focused laser beams but do not have the protection of a cutoff circuit. In short, there are no safety mechanisms generally in use that would prevent either inadvertent or, in the hands of a child through the actions of curiosity or play, potentially hazardous eye exposure to multiple laser beams from a home care product. To quote the IEC for a typical class IIIR product "The laser beams from these products exceed the maximum permissible exposure for accidental viewing and can potentially cause eye injuries, but the actual risk of injury following a short, accidental exposure, is still small". But how small a risk is acceptable for a home use product design?
Sunetics has taken a very different approach. Through our laser research and design, we have found that by using the natural beam divergence (the natural spreading of the laser from its emission from the laser diode), which is generally about 10 degrees, we could create a natural field of coherent laser energy equivalent to the state of the art for laser hair therapy products and include a built in product safety factor.
What does this mean in the real world? First, at the distance normally used in the Sunetics product (1 1/2" from the laser emissions in the Model G clinical laser units and at the
1" distance for the length of the bristles of the Sunetics Laser Hair Brush) the natural spread of the coherent laser energy creates the equivalent output of the focused, or collimated devices. Part of this is due to the short distance from the laser to the treatment area and part of this due to the inherent overlapping of the laser energy in the treatment field. Another by-product of this design is the ability to provide a full field of coherent laser energy coverage over the treated area as opposed to the traditional, or laser spot, products.
From a safety perspective, the natural divergence of the laser energy spreads very quickly once past the treatment area. Since the lasers are not collimated there is no risk of accidental exposure to the eye from a focused laser energy beam. This means that Sunetics laser products can have a laser safety rating better than even a simple laser pointer. Per the IEC, "Class 1M lasers are products which produce either a highly divergent beam or a large diameter beam. Therefore, only a small part of the whole laser beam can enter the eye. However, these laser products can be harmful to the eye if the beam is viewed using magnifying optical instruments." This effectively means that unless you are looking at the lasers through a magnifying lens, you are in no risk of eye damage.
In the end, this design in Sunetics opinion makes for a more effective and safer product design than the current standard of product on the market. Regardless if it’s the Clinical Laser System (which is afforded a cleaner design due to its inherent safety) or the Laser Hair Brush (reduced risk of accidental eye injury for home use), our continued innovation will lead the way for physician and consumer use.
Don't misunderstand, used properly the majority of the products in the laser hair treatment industry are safe if used properly and meet FDA and CDRH standards.
Sunetics feels our overall design provides a superior edge in technology and safety.
So, the next time someone compares our products to the competition, now you know the facts.
Charles E. Maricle PhD
Sunetics International Corp.
4760 Pecos Road suite 103
Las Vegas, Nevada 89121
(877) 777-8818
www.sunetics.com
Laser Safety Officer
Member, Laser Institute of America www.laserinstitute.org
Member, International Laser Display Association www.laserist.org
Member, American Society for Laser Medicine and Surgery www.aslms.org
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