510(k) K152357

MicroSTAAR Injector System Cartridges by STAAR Surgical Company — Product Code KYB

K152357 is an FDA 510(k) premarket notification submitted by STAAR Surgical Company for the device "MicroSTAAR Injector System Cartridges". The FDA issued a decision of Substantially Equivalent on October 30, 2015. The device falls under product code KYB (Lens, Guide, Intraocular), a Class I device regulated under 21 CFR 886.4300. STAAR Surgical Company has at least 10 other 510(k) clearances on record.