510(k) K111882

LAMINAR FLOW PHACO TIPS by Abbott Medical Optics, Inc. — Product Code HQC

K111882 is an FDA 510(k) premarket notification submitted by Abbott Medical Optics, Inc. for the device "LAMINAR FLOW PHACO TIPS". The FDA issued a decision of Substantially Equivalent on November 7, 2011. The device falls under product code HQC (Unit, Phacofragmentation), a Class II device regulated under 21 CFR 886.4670. Abbott Medical Optics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 7, 2011
Date Received
July 1, 2011
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Phacofragmentation
Device Class
Class II
Regulation Number
886.4670
Review Panel
OP
Submission Type