510(k) K053333

EAGLEVISION GELLANSERTS, MODEL REF 0040 by Eagle Vision, Inc. — Product Code LZU

K053333 is an FDA 510(k) premarket notification submitted by Eagle Vision, Inc. for the device "EAGLEVISION GELLANSERTS, MODEL REF 0040". The FDA issued a decision of Substantially Equivalent on May 2, 2006. The device falls under product code LZU (Plug, Punctum), a Class U device. Eagle Vision, Inc. has at least 6 other 510(k) clearances on record.