510(k) K050638

LENSTEC INTRAOCULAR LENS (IOL) INJECTION SYSTEM FOR TETRAFLEX INTRAOCULAR LENSES by Lenstec, Inc. — Product Code MSS

K050638 is an FDA 510(k) premarket notification submitted by Lenstec, Inc. for the device "LENSTEC INTRAOCULAR LENS (IOL) INJECTION SYSTEM FOR TETRAFLEX INTRAOCULAR LENSES". The FDA issued a decision of Substantially Equivalent on May 31, 2005. The device falls under product code MSS (Folders And Injectors, Intraocular Lens (Iol)), a Class I device regulated under 21 CFR 886.4300. Lenstec, Inc. has at least 5 other 510(k) clearances on record.