Cleared Traditional

K040231 - INTELIPORT OCCLUDING DEVICE

K040231 · Alcon, Inc. · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
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.

FDA 510(k) Submission Details - K040231

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
52d slower than avg
Panel avg: 110d · This submission: 162d
Pathway characteristics
Predicate-based equivalence.

LZU Device Classification - Class 0,

Product Code LZU Plug, Punctum
Device Class -

Regulatory Peers - LZU Plug, Punctum

All 45
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K021936 · Moist Medical, Inc. · Oct 2002
K040231 · INTELIPORT OCCLUDING DEVICE
Download PDF FDA Summary Alcon, Inc.