Cleared Traditional

K121721 - LAMINAR FLOW PHACO TIPS AND IRRIGATION SLEEVE (21G, REUSABLE) (FDA 510(k) Clearance)

Class II Ophthalmic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K121721 · Abbott Medical Optics, Inc. · Ophthalmic device
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Oct 2012
Decision
125d
Days
Class 2
Risk

K121721 is an FDA 510(k) clearance for the LAMINAR FLOW PHACO TIPS AND IRRIGATION SLEEVE (21G, REUSABLE). 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 October 15, 2012 after a review of 125 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 Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

View all Abbott Medical Optics, Inc. devices

Submission Details

510(k) Number K121721 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 12, 2012
Decision Date October 15, 2012
Days to Decision 125 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
15d slower than avg
Panel avg: 110d · This submission: 125d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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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