danya
December 31st, 2003, 07:32 AM
Another Medical Milestone for the HairMAX LaserComb - Now a Class 2A Medical Device by the Health Science Authority Singapore
Another medical milestone for the HairMAX LaserComb as a class 2A medical device in Singapore and complies with all safety, quality and performance requirements for treatment of hair loss and hair re-growth.
SINGAPORE, SINGAPORE (PRWEB) December 31, 2003 -- The Hair Max Laser Comb, A Low Level Laser Device for the treatment of hairloss and related hair and scalp problems received certification by the Singapore Government, Health Science Authority as a Class 2a Medical Device having met the quality, safety and performances standards as a medical device for Low Level Laser Therapy (LLLT) to scalp and hair follicles in men and women.
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.
Based on appropriate scientific information and clinical data submitted to Health Science Authority Singapore, and after examination of all data submitted, and after having satisfied that the Hair Max Laser Comb complies with all safety, quality and performance standards of a medical device, the Center for Medical Device Regulation (CMDR) classified the Hair Max Laser Comb as a Class 2a 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. The CMDR in Singapore is benchmarked to US FDA, EU Medical Device Directive, the 93/42/EEC as well as the Global Harmonization Task Force, therefore having a Class 2a classification by HSA Singapore 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 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 10,000 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.
Another medical milestone for the HairMAX LaserComb as a class 2A medical device in Singapore and complies with all safety, quality and performance requirements for treatment of hair loss and hair re-growth.
SINGAPORE, SINGAPORE (PRWEB) December 31, 2003 -- The Hair Max Laser Comb, A Low Level Laser Device for the treatment of hairloss and related hair and scalp problems received certification by the Singapore Government, Health Science Authority as a Class 2a Medical Device having met the quality, safety and performances standards as a medical device for Low Level Laser Therapy (LLLT) to scalp and hair follicles in men and women.
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.
Based on appropriate scientific information and clinical data submitted to Health Science Authority Singapore, and after examination of all data submitted, and after having satisfied that the Hair Max Laser Comb complies with all safety, quality and performance standards of a medical device, the Center for Medical Device Regulation (CMDR) classified the Hair Max Laser Comb as a Class 2a 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. The CMDR in Singapore is benchmarked to US FDA, EU Medical Device Directive, the 93/42/EEC as well as the Global Harmonization Task Force, therefore having a Class 2a classification by HSA Singapore 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 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 10,000 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.