Cleared Abbreviated

K111697 - AMO WHITESTAR SIGNATURE PHACOEMULSIFICATION SYSTEM (FDA 510(k) Clearance)

Class II Ophthalmic device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K111697 · Abbott Medical Optics, Inc. · Ophthalmic device
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Sep 2011
Decision
102d
Days
Class 2
Risk

K111697 is an FDA 510(k) clearance for the AMO WHITESTAR SIGNATURE PHACOEMULSIFICATION SYSTEM. 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 27, 2011 after a review of 102 days - within the typical 510(k) review window.

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

Submission Details

510(k) Number K111697 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 17, 2011
Decision Date September 27, 2011
Days to Decision 102 days
Submission Type Abbreviated
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
8d faster than avg
Panel avg: 110d · This submission: 102d
Pathway characteristics
Standards-based clearance path.

Device Classification

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 314
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