For Immediate Release
雷射健髮梳在新加坡明確作為醫療器材
December 30, 2003 (Boca Raton) The HairMax LaserComb (a hand-held Laser PhotoTherapy device for thicker, fuller, healthier hair) has been classified as a Class 2a Medical Device in Singapore. The LaserComb was found to comply with quality, safety and performance requirements set forth by the Health Sciences Authority for medical devices.
中文簡略說明
2003年 ( Boca Raton ) 12月30日把 HairMax LaserComb (為密集的, 更完全的, 更健康頭髮的雷射光療法裝置) 在新加坡已經分類為 Class 2a 醫療裝置。LaserComb 被找到順從性品質, 安全和表現的需要由健康科學當局對於醫療裝置。
"This is another step toward establishing the credibility of the LaserComb as an effective device for promoting thicker, healthier hair in both men and women for the international market" stated David Michaels, Managing Director of Lexington International, developer of the HairMax LaserComb.
中文簡略說明
"這是對於作為用增進人們和國際市場的女人中的密集(厚)(粗)的,更健康頭髮的一個有效裝置建立 LaserComb 的可信性的另一個步(步驟)" 指定David Michaels為Lexington International經理主管也是HairMax LaserComb的開發者。
Lexington International is a manufacturer of laser healthcare devices headquartered in Boca Raton, Florida. Lexington's flagship product, the HairMax LaserComb is the first hand-held laser phototherapy device of its kind and is sold in 63 countries around the world.
中文簡略說明
萊星頓國際是屬於雷射健康儀器的製造商總部設置在佛羅里達Boca Raton.萊星頓的旗艦產品,HairMax LaserComb是第一支手握式的光線療法儀器種類而且在世界周圍的63個國家中賣。這個LaserComb是由新加坡DermaLogix Cosmedics分發為醫學儀器規則中的檔案裏
The LaserComb is distributed in Singapore by DermaLogix Cosmedics which filed the submission with the Centre for Medical Device Regulation.
中文簡略說明
這個LaserComb是由新加坡DermaLogix Cosmedics分發為醫學中心儀器規則中的檔案裏。
"The Centre for Medical Device Regulation in Singapore is benchmarked to US FDA, European Union 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 Timothy Chan, Managing Director of DermaLogix Cosmedics. DermaLogix also provides cultural expertise in the field of marketing and advertising of the LaserComb to Asian markets.
"We seek to work closely with distributors like DermaLogix in the international market because of their sales experience and knowledge of medical device requirements" said Randy Veliky, Chief Operating Officer for Lexington International. "Our goal is to expand sales in the Asian market while certifying that the LaserComb complies with all standards for quality and safety."
HairMax has been gaining recognition as an effective treatment for thinning hair with government agencies and medical professionals worldwide. The LaserComb has previously been classified as a Class 2 Medical Device in Canada effective in "stopping hair loss and re-growing hair in both men and women" and is currently under review by the United States FDA to be cleared for similar claims.
＞Caitian,LLC 