510(k) K954600

MICROSTAAR INJECTOR MODELS MSI-TD & MSI-PD (MODIFICATION) by Staar Surgical Co. — Product Code KYB

K954600 is an FDA 510(k) premarket notification submitted by Staar Surgical Co. for the device "MICROSTAAR INJECTOR MODELS MSI-TD & MSI-PD (MODIFICATION)". The FDA issued a decision of Substantially Equivalent on December 21, 1995. 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.