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The FDA has granted 510(k) clearance to Paragon BioTeck’s Comfortear Lacrisolve absorbable punctum plug.
Portland, OR-The FDA has granted 510(k) clearance to Paragon BioTeck’s Comfortear Lacrisolve absorbable punctum plug.
“Receiving FDA 510(k) clearance for this device is an important milestone for Paragon,” said Lauren M-C Bluett, director of quality assurance for Paragon. “Dry eye affects over 4.8 million people in the United States and (the device keeps) with Paragon’s ultimate goal to protect and preserve eyesight.”
According to the company, the devices are medium-term implants designed to be inserted into the canaliculus in order to block tear drainage through the lacrimal drainage system.
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