510(k) K151783

COMPACT INTUITIV Multiple-Use Pack by Abbott Medical Optics, Inc. — Product Code HQC

K151783 is an FDA 510(k) premarket notification submitted by Abbott Medical Optics, Inc. for the device "COMPACT INTUITIV Multiple-Use Pack". The FDA issued a decision of Substantially Equivalent on September 2, 2015. 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
September 2, 2015
Date Received
July 1, 2015
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