510(k) K983129

DISPOSABLE MICROSTAAR INJECTOR (MODEL MSI-P1) by Staar Surgical Co. — Product Code KYB

K983129 is an FDA 510(k) premarket notification submitted by Staar Surgical Co. for the device "DISPOSABLE MICROSTAAR INJECTOR (MODEL MSI-P1)". The FDA issued a decision of Substantially Equivalent on December 4, 1998. The device falls under product code KYB (Lens, Guide, Intraocular), a Class I device regulated under 21 CFR 886.4300. Staar Surgical Co. has at least 10 other 510(k) clearances on record.