Sunetics' Clinical Laser System for Hair the First to Comply With U.S. and International Standards
Sunetics International's clinical laser system is the first to be cleared for medical office installation in the U.S. and European markets.
Las Vegas, NV (PRWEB) September 24, 2007 -- Sunetics International is the first company to achieve certification by independent labs for its clinical laser system in compliance with both CE and UL standards for medical laser devices.
"Sunetics International is committed to providing the very best quality in both its clinical and consumer laser systems," said Dr. Charles Maricle, Chief Technology Officer of Sunetics International. "This important certification is further proof of Sunetics' commitment and its technological superiority to other products on the market."
The company's CE compliance makes it the first U.S. company to be approved to install its clinical laser hood systems at medical centers in the European Union, as well as other countries that require CE compliance.
Additionally, with Sunetics' UL 60601 compliance, it becomes the first company to meet U.S. compliance standards to install its laser hood systems in doctors' offices, clinics and other medical centers.
Any hair laser system which is installed into a medical practice must comply (dependent on international or domestic use) with one of the above standards. In the U.S., a product must be independently tested and comply with UL 60601 before a doctor or medical director can legally install it into their business. In some jurisdictions, if a device is found not to have compliance then the doctor may lose his business operating permits.
CE Standards Compliance for a Class 1 Medical Device:
Safety Test Standards: IEC/EN 60601-1 and EN 60825-1 Medical Electrical Equipment Safety of Lasers
EMC Test Standard: Essential Performance: IEC/EN 60601-1-2 Risk Assessment and Immunity with Specified Exceptions.
Testing Lab: Garwood Laboratories Inc., a Competent,Independent 3rd Party Test Laboratory located in San Clemente, California, USA, as is documented by Technical Construction File, SIL- 070830-1, available on request.
UL Standards Compliance for a Medical Device:
Safety Test Standards: UL 60601-1 Medical Electrical Equipment, General Requirements for Safety including laser products
Testing Lab: The equipment was evaluated in accordance with the applicable sections of the National Electrical Code (NEC), the Recommended Practice and Procedures for Unlabeled Electrical Equipment Evaluation 1st edition (ACES and ACIL) and the US UL Standards by MET Laborotories, 2200 Gateway Centre Blvd., Suite 215, Morrisville, North Carolina
Laser Therapy Effective at Treating Hair Loss:
"Low level laser therapy has shown great potential for treating certain types of male and female hair loss," said Alan J. Bauman, M.D., a prominent hair restoration physician and top U.S. expert on hair loss. "Laser therapy is an important part of a multi-therapy approach to restoring lost hair."
Dr. Bauman has been using Sunetics' laser devices since 2003. According to Dr. Bauman, low level laser therapy is believed to reactivate hair growth by stimulating live, but weakened, follicles at the cellular level.
In January of 2007, the U.S. Food and Drug Administration officially cleared a hand-held laser device to treat hair loss and regrow hair - the first time low level laser therapy has been officially recognized by the government for its hair restoration capabilities.
Sunetics International's own clinical surveys have shown that as a result of its laser therapy program, 86-percent of patients reported healthier hair, 78-percent claimed to have thicker hair and 76-percent had fuller hair. And 85-percent of clients reported overall satisfaction.
Sunetics International is a leading U.S. manufacturer of low level laser products that are regularly used by doctors for the treatment of weak or thinning hair. Sunetics also offers devices for acne, wrinkles and skin rejuvenation. Established in 2003, Sunetics is a registered cosmetic manufacturer with the FDA and provides both hand-held laser devices and in-office laser units. For more information about low level laser devices or products from Sunetics, visit www.sunetics.com or call 1-888-266-2232, or email at