• 510(k) Filing Strategy Could Become Used More After Successful Launch of Eye Device

    The 510(k) approval process used by North Carolina company TearScience could represent a new and imitable strategy for other companies to follow, said TearScience CEO Tim Willis in remarks to Med City News on 7 February . The company's device, the LipiFlow Thermal Pulsation System, is used to treat dry eye by clearing channels that supply the eye with moisture-retaining oils. The company applied for 510(k) clearance in two separate filings, and received clearance ...