Cleared Traditional

K191650 - LEGION System

K191650 is the FDA 510(k) clearance for LEGION System by Alcon Research, LLC. It is a Class 2 Ophthalmic device (product code HQC) cleared through the Traditional 510(k) pathway after a 134-day FDA review.

K191650 · Alcon Research, LLC · Ophthalmic device
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Nov 2019
Decision
134d
Days
Class 2
Risk

K191650 is an FDA 510(k) clearance for the LEGION System. Classified as Unit, Phacofragmentation (product code HQC), Class II - Special Controls.

Submitted by Alcon Research, LLC (Fort Worth, US). The FDA issued a Cleared decision on November 1, 2019 after a review of 134 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 Alcon Research, LLC devices

Submission Details

510(k) Number K191650 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 20, 2019
Decision Date November 01, 2019
Days to Decision 134 days
Submission Type Traditional
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
24d slower than avg
Panel avg: 110d · This submission: 134d
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 80
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