510(k) K191949

UNFOLDER Vitan Inserter by Johnson & Johnson Surgical Vision, Inc. — Product Code MSS

K191949 is an FDA 510(k) premarket notification submitted by Johnson & Johnson Surgical Vision, Inc. for the device "UNFOLDER Vitan Inserter". The FDA issued a decision of Substantially Equivalent on September 13, 2019. The device falls under product code MSS (Folders And Injectors, Intraocular Lens (Iol)), a Class I device regulated under 21 CFR 886.4300. Johnson & Johnson Surgical Vision, Inc. has at least 3 other 510(k) clearances on record.