510(k) K063694

AKREOS SINGLE USE INSERTION DEVICE, MODEL AI-28 by Bausch & Lomb, Inc. — Product Code KYB

K063694 is an FDA 510(k) premarket notification submitted by Bausch & Lomb, Inc. for the device "AKREOS SINGLE USE INSERTION DEVICE, MODEL AI-28". The FDA issued a decision of Substantially Equivalent on March 7, 2007. The device falls under product code KYB (Lens, Guide, Intraocular), a Class I device regulated under 21 CFR 886.4300. Bausch & Lomb, Inc. has at least 10 other 510(k) clearances on record.