Cleared Traditional

ENTRY SITE ALIGNMENT SYSTEM MODEL # CX9626 (K012435) - FDA 510(k) Clearance

Class I Ophthalmic device.

K012435 · Bausch & Lomb, Inc. · Ophthalmic device
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Oct 2001
Decision
63d
Days
Class 1
Risk

K012435 is an FDA 510(k) clearance for the ENTRY SITE ALIGNMENT SYSTEM MODEL # CX9626. Classified as Cannula, Trocar, Ophthalmic (product code NGY), Class I - General Controls.

Submitted by Bausch & Lomb, Inc. (St. Louis, US). The FDA issued a Cleared decision on October 2, 2001 after a review of 63 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4350 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Bausch & Lomb, Inc. devices

Submission Details

510(k) Number K012435 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 2001
Decision Date October 02, 2001
Days to Decision 63 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
47d faster than avg
Panel avg: 110d · This submission: 63d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code NGY Cannula, Trocar, Ophthalmic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.4350
Definition The Trocar/cannula Set Is A Manual Surgical Instrument Intended For Use As Single-use, Disposable Cannula System For Establishing An Entry Site Conduit For Passing Ophthalmic Instruments Used To Perform Posterior Ophthalmic Surgical Procedures.
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.