Cleared Traditional

INTELIPORT OCCLUDING DEVICE (K040231) - FDA 510(k) Clearance

K040231 · Alcon, Inc. · Ophthalmic device
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Optimized for regulatory review, auditing and printing
Jul 2004
Decision
162d
Days
-
Risk

K040231 is an FDA 510(k) clearance for the INTELIPORT OCCLUDING DEVICE. Classified as Plug, Punctum (product code LZU).

Submitted by Alcon, Inc. (Fort Worth, US). The FDA issued a Cleared decision on July 13, 2004 after a review of 162 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel. 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, Inc. devices

Submission Details

510(k) Number K040231 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 02, 2004
Decision Date July 13, 2004
Days to Decision 162 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
52d slower than avg
Panel avg: 110d · This submission: 162d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LZU Plug, Punctum
Device Class -