Cleared Traditional

K001768 - OCCU-FLO PUNCTUM PLUGS

K001768 · U.S. Iol, Inc. · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
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.

FDA 510(k) Submission Details - K001768

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
11d faster than avg
Panel avg: 110d · This submission: 99d
Pathway characteristics
Predicate-based equivalence.

LZU Device Classification - Class 0,

Product Code LZU Plug, Punctum
Device Class -

Regulatory Peers - LZU Plug, Punctum

All 45
Devices cleared under the same product code (LZU) and FDA review panel - the closest regulatory comparables to K001768.
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OPAQUE HERRICK PLUG, 0.3MM
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FLEXPLUG
K991130 · Eagle Vision, Inc. · Apr 1999
K001768 · OCCU-FLO PUNCTUM PLUGS
Download PDF FDA Summary U.S. Iol, Inc.