PORTLAND, Ore. — Paragon BioTeck, Inc., a privately held biopharmaceutical and medical device company specializing in the development of ophthalmic pharmaceuticals, devices and therapies, announced today that it has received CE mark approval for the recently FDA cleared Comfortear® Lacrisolve™ Absorbable Punctum Plug. CE mark approval is recognized and associated with safety and performance in multiple countries.
“Receiving FDA 510(k) clearance for this device was an important milestone for Paragon. Now receiving the CE mark approval will allow additional commercialization throughout the European Union. In keeping with Paragon’s ultimate goal to protect and preserve eyesight, the Comfortear® Lacrisolve™ Absorbable Punctum Plug is a great addition to our portfolio of ophthalmic products,” said Lauren M-C Bluett, Director of Quality Assurance.
About Comfortear® Lacrisolve™ Absorbable Punctum Plug
Comprised of the synthetic absorbable polymer, polydioxanone, the Comfortear® Lacrisolve™ Absorbable Punctum Plugs are medium-term implants designed to be inserted into the canaliculus in order to block tear drainage through the lacrimal drainage system. The Comfortear® Lacrisolve™ Absorbable Punctum Plugs are available in two diameters: 0.4mm and 0.5mm. The implants are supplied sterile with two implants per package.
Absorption time for the Comfortear® Lacrisolve™ Absorbable Punctum Plugs is approximately 6 months (=<6). For full prescribing information, visit paragonbioteck.com.
About Paragon BioTeck, Inc.
Paragon BioTeck, Inc., is a privately held ophthalmic-focused biopharmaceutical and medical device company pursuing the development and commercialization of products addressing unmet medical needs in the fight to protect and preserve eyesight.
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