Palomar to Seek OK on Hair Removal Device
Palomar Medical Technologies Inc., a Burlington, Mass., developer of light-based systems for cosmetic treatments, announced today it will seek approval from the US Food and Drug Administration (FDA) to market a light-based hair removal device for home use. Palamor was given the go-ahead by The Gillette Co. as part of a license agreement the companies made in February 2003, before Gillette was acquired by Procter & Gamble. If Palomar receives a 510k over-the-counter (OTC) clearance from the FDA, Gillette will make a development completion payment to Palomar of $2.5 million within 30 days. OTC clearance allows products to be marketed and sold directly to consumers without a prescription in the US. Palomar also has an agreement with Johnson & Johnson Consumer Cos. to develop home-use, light-based devices for reducing or reshaping body fat including cellulite, reducing the appearance of skin aging and reducing or preventing acne. It was also awarded a contract by the US Army to develop a light-based, self-treatment device for pseudofolliculitis barbae (razor bumps).