510(k) K161776

Lenstec LC Injection system by Lenstec, Inc. — Product Code MSS

K161776 is an FDA 510(k) premarket notification submitted by Lenstec, Inc. for the device "Lenstec LC Injection system". The FDA issued a decision of Substantially Equivalent on November 29, 2016. 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.