FDA MARKETING CLEARANCE SOUGHT FOR PATENTED LASER HAIR REMOVAL SYSTEM
From: PR Newswire
GAINESVILLE, Fla., May 31 /PRNewswire/ -- A Pre-market Notification [FDA form 510(k)] was filed yesterday by Classy Lady by Mehl of Puerto Rico, Inc., with the Food and Drug Administration (FDA) seeking marketing clearance for a new hair removal process that uses a patented health-care laser system. The filing offers supportive and pivotal clinical studies which demonstrate that the process safely removes unwanted hair in both men and women.
An FDA 510(k) submission is normally called for 90 days prior to marketing a new device in the United States.
"We believe our laser hair ...
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