Cleared Abbreviated

K151783 - COMPACT INTUITIV Multiple-Use Pack

K151783 is an FDA 510(k) clearance for COMPACT INTUITIV Multiple-Use Pack, manufactured by Abbott Medical Optics, Inc.. The device is a Class 2 Ophthalmic device with product code HQC cleared through the Abbreviated 510(k) pathway after a 63-day FDA review.

K151783 · Abbott Medical Optics, Inc. · Ophthalmic device
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Sep 2015
Decision
63d
Days
Class 2
Risk

K151783 is an FDA 510(k) clearance for the COMPACT INTUITIV Multiple-Use Pack. Classified as Unit, Phacofragmentation (product code HQC), Class II - Special Controls.

Submitted by Abbott Medical Optics, Inc. (Santa Ana, US). The FDA issued a Cleared decision on September 2, 2015 after a review of 63 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4670 - the FDA ophthalmic device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Abbott Medical Optics, Inc. devices

FDA 510(k) Submission Details - K151783

510(k) Number K151783 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 2015
Decision Date September 02, 2015
Days to Decision 63 days
Submission Type Abbreviated
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
47d faster than avg
Panel avg: 110d · This submission: 63d
Pathway characteristics
Standards-based clearance path.

HQC Device Classification - Class 2, Special Controls

Product Code HQC Unit, Phacofragmentation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.4670
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ophthalmic devices follow this clearance model.

Regulatory Peers - HQC Unit, Phacofragmentation

All 208
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