Marlborough firm’s medical device gets FDA nod to treat new skin conditions
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Marlborough medical device company Candela Corp. has received clearance from the U.S. Food & Drug Administration to use the company’s laster system to treat melasma, a skin condition frequently arising during pregnancy, among other times.
Previously the PicoWay Laser was approved for use in treating benign pigmented lesions, tattoo removal, and for use on wrinkles and acne scars, according to Candela’s press release on Wednesday announcing the FDA clearance. Candela’s line of devices, most laser-based, treat a variety of aesthetic medical conditions, from scar revision to hair removal.
Melasma, caused by hormonal changes or sun exposure, is a benign skin condition creating darker patches of skin, often on the face. It is more common in women than men, occurs frequently during pregnancy, and impacts mostly medium to dark skin tones, according to the American Academy of Dermatology.
The new FDA clearance also allows for use treating other discoloration of the skin and eyes: lentigines, café au lait macules, and Nevus of Ota.
Candela’s PicoWay Laser reduces the risk for hypo- or hyperpigmentation that can result from excess heat delivery from other lasers in individuals with darker skin tones, according to a Wednesday press release from Candela.
“Addressing melasma with the PicoWay laser gives patients an important treatment modality to manage this difficult and often psychologically upsetting condition. Patients now have a treatment that specifically targets their pigmentary changes and can be used alongside other treatments like topicals to better manage this complex skin disorder," Dr. Douglas Wu, a dermatologist at Cosmetic Laser Dermatology in San Diego, said in the press release.
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