510(k) K091507

RAYNER SMALL INCISION SINGLE USE SOFT TIPPED INJECTOR, MODEL R-INJ-04/18 by Rayner Intraocular Lenses , Ltd. — Product Code MSS

K091507 is an FDA 510(k) premarket notification submitted by Rayner Intraocular Lenses , Ltd. for the device "RAYNER SMALL INCISION SINGLE USE SOFT TIPPED INJECTOR, MODEL R-INJ-04/18". The FDA issued a decision of Substantially Equivalent on December 4, 2009. The device falls under product code MSS (Folders And Injectors, Intraocular Lens (Iol)), a Class I device regulated under 21 CFR 886.4300. Rayner Intraocular Lenses , Ltd. has at least 3 other 510(k) clearances on record.