510(k) K132002

SINGLE USE SOFT TIPPED DISPOSABLE INJECTOR, RAYSERT SINGLE USE SOFT TIPPED SMALL INCISION DISPOSABLE INJECTOR by Rayner Intraocular Lenses , Ltd. — Product Code MSS

K132002 is an FDA 510(k) premarket notification submitted by Rayner Intraocular Lenses , Ltd. for the device "SINGLE USE SOFT TIPPED DISPOSABLE INJECTOR, RAYSERT SINGLE USE SOFT TIPPED SMALL INCISION DISPOSABLE INJECTOR". The FDA issued a decision of Substantially Equivalent on March 27, 2014. 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.