510(k) K892204

NIDEK INC. MODELS YC-2000 & 3000 OPHTHALMIC LASERS by Nidek, Inc. — Product Code LXS

K892204 is an FDA 510(k) premarket notification submitted by Nidek, Inc. for the device "NIDEK INC. MODELS YC-2000 & 3000 OPHTHALMIC LASERS". The FDA issued a decision of Substantially Equivalent on June 22, 1989. The device falls under product code LXS (Laser, Neodymium:Yag, Ophthalmic For Posterior Capsulotomy And Cutting Pupilla), a Class II device regulated under 21 CFR 886.4392. Nidek, Inc. has at least 10 other 510(k) clearances on record.