Cleared Traditional

K030300 - OPAQUE HERRICK LACRIMAL PLUG (FDA 510(k) Clearance)

K030300 · Lacrimedics, Inc. · Ophthalmic device
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Optimized for regulatory review, auditing and printing
May 2003
Decision
100d
Days
-
Risk

K030300 is an FDA 510(k) clearance for the OPAQUE HERRICK LACRIMAL PLUG. Classified as Plug, Punctum (product code LZU).

Submitted by Lacrimedics, Inc. (Eastsound, US). The FDA issued a Cleared decision on May 9, 2003 after a review of 100 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 Lacrimedics, Inc. devices

Submission Details

510(k) Number K030300 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 29, 2003
Decision Date May 09, 2003
Days to Decision 100 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
10d faster than avg
Panel avg: 110d · This submission: 100d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LZU Plug, Punctum
Device Class -