Medical Device for Hair Loss

Discussion in 'Health and medical' started by Better Hair 98, Jan 25, 2004.

  1. SINGAPORE, 23 December 2003. The Hair Max Laser Comb, A Low Level Laser
    Device for the treatment of hairloss and related hair and scalp problems is
    now marketed as a Class 2a medical device in Singapore. For more information
    visit : http://www.dermalogix.net

    The Hair Max Laser Comb, manufactured by Lexington International LLC, is a breakthrough personal
    device for delivering the healthy, nourishing effects of Low Level Laser Therapy (LLLT) to hair.
    LLLT uses the stimulating effects of laser light in the natural, scientific process known as Photo
    BioStimulation to also improve the quality and thickness of hair.

    The HairMAX laserComb receives marketing clearances to be marketed in Singapore as a Class2a medical
    device since it complies with all safety, quality and performance standards of a medical device (
    Registration number 728-2003-1) .

    "This is another great milestone as the Hair Max Laser Comb was first granted a Class 2 medical
    license by the Government of Canada in January 2003. Getting marketing clearances in Singapore is an
    important steps since Singapore is benchmarked towards US FDA, EU Medical Device Directive, the
    93/42/EEC as well as the Global Harmonization Task Force, therefore having a Class 2a classification
    shows that the Hair Max Laser Comb complies fully with all safety, quality and performances
    standards and requirements set forth by the FDA, the EU, EEC and the GHTF" according to Mr
    Timothy Chan, Managing Director of DermaLogix Cosmedics " and we do wish that more and more
    people would be able to benefit from this form of safe and effective LLLT for hairloss and
    related hair and scalp problems."

    A recent clinical study "Hair Re-growth and Increase Hair Tensile Strength Using the HairMAX
    LaserComb for Low Level Laser Therapy" published in the International Journal of Cosmetics Surgery
    and Aesthetic Dermatology (Vol. 5, No.2, 2003) - also document that the Hair Max Laser Comb as an
    effective LLLT treatment to stimulate hair growth. Out of 35 patients on clinical trial all (man and
    woman) shows an increase in hair count and improve in hair strength. On the average all man and
    woman shows an 93.5% increase in hair count and 86.4% improve in hair strength.

    "Many people in Asia have been short changed by paying for un-proven treatments sold by hair care
    centers. It's like paying first class price for below executive class value. Many people with
    hairloss problems are not getting real value for their money" added Mr. Adrian Lim, Manager at
    DermaLogix Cosmedics " it is always our company's vision to offer first class value at executive
    price and we can now do it with the Hair Max laser Comb."

    The Hair Max Laser Comb has been undergoing Clinical Trials throughout 2002. Clinical data will also
    be presented to the US FDA in mid 2003 for similar medical claims to be made to the American public.
    Currently, the Hair Max Laser Comb is classified as a Cosmetic Device in the USA that promotes
    thicker, fuller, healthier hair.

    The Laser Comb complies with FDA regulations for laser safety (section 21) and is patented in the
    USA with patents pending in 104 countries around the world.

    The Hair Max Laser Comb debuted in March 2001 and has received wide public and press attention. The
    Hair Max Laser Comb has been highlighted by TIME Magazine as one of the "Inventions of the Year". To
    date, the Hair Max Laser Comb has well over 50,000 satisfied users in 54 countries.

    Lexington International had its beginnings in Sydney, Australia where a prototype of the Laser Comb
    was developed. The company moved its headquarters to Boca Raton on Florida's Internet Coast in 2000,
    where the Hair Max Laser Comb is also manufactured.
     
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