Cleared Traditional

OCCU-FLO PUNCTUM PLUGS (K001768) - FDA 510(k) Clearance

K001768 · U.S. Iol, Inc. · Ophthalmic device
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Optimized for regulatory review, auditing and printing
Sep 2000
Decision
99d
Days
-
Risk

K001768 is an FDA 510(k) clearance for the OCCU-FLO PUNCTUM PLUGS. Classified as Plug, Punctum (product code LZU).

Submitted by U.S. Iol, Inc. (Lexington, US). The FDA issued a Cleared decision on September 19, 2000 after a review of 99 days - within the typical 510(k) review window.

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 U.S. Iol, Inc. devices

Submission Details

510(k) Number K001768 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 12, 2000
Decision Date September 19, 2000
Days to Decision 99 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
11d faster than avg
Panel avg: 110d · This submission: 99d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LZU Plug, Punctum
Device Class -