510(k) K040204

ZYOPTIX XP MICROKERATOME by Bausch & Lomb, Inc. — Product Code HNO

K040204 is an FDA 510(k) premarket notification submitted by Bausch & Lomb, Inc. for the device "ZYOPTIX XP MICROKERATOME". The FDA issued a decision of Substantially Equivalent on March 22, 2004. The device falls under product code HNO (Keratome, Ac-Powered), a Class I device regulated under 21 CFR 886.4370. Bausch & Lomb, Inc. has at least 10 other 510(k) clearances on record.