US-based medical device company Paragon BioTeck has obtained CE mark approval for its Comfortear Lacrisolve Absorbable Punctum Plug.
The Comfortear Lacrisolve Absorbable Punctum Plugs are medium-term implants, developed to insert into the canaliculus, in order to block tear drainage through the lacrimal drainage system.
Available in two diameters, 0.4mm and 0.5mm, the Comfortear comprises synthetic absorbable polymer. The company said that the implants are supplied sterile with two implants per package.
Paragon BioTeck quality assurance director Lauren M-C Bluett said: "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."
Paragon BioTeck is specialized in the development of ophthalmic pharmaceuticals, devices and therapies.