ENDYMED LTD EndyMed Ltd. announced that it has obtained US Food and Drug Administration (FDA) approval for its product, Newa, for the treating wrinkles and fractional skin resurfacing. The approval comes two weeks after Health Canada approved the product, and allows the company to prepared for its commercial launch in both countries. The FDA approved the Newa devices through its K510 track, and classified it as a Class II device for delicate and medium facial wrinkles, in line with FDA marketing guidelines for the annual registration of the product, good manufacturing, and labeling.
The FDA has already approved two EndyMed products for the professional market, the EndyMed Pro and the EndyMed Glow/Pure. EndyMed began sales of the EndyMed Pro in 2009 and the EndyMed Glow in 2012. It is now entering the home market, another important market for the company, after previously only targeting the professional market: private clinics, dermatologists, general practitioners, and cosmeticians.
