Cleared Traditional

K030300 - OPAQUE HERRICK LACRIMAL PLUG

K030300 · Lacrimedics, Inc. · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
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.

FDA 510(k) Submission Details - K030300

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
10d faster than avg
Panel avg: 110d · This submission: 100d
Pathway characteristics
Predicate-based equivalence.

LZU Device Classification - Class 0,

Product Code LZU Plug, Punctum
Device Class -

Regulatory Peers - LZU Plug, Punctum

All 48
Devices cleared under the same product code (LZU) and FDA review panel - the closest regulatory comparables to K030300.
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K040231 · Alcon, Inc. · Jul 2004
SMART PLUG, MODEL 500
K022043 · Medennium, Inc. · Oct 2002
MOIST PUNCTAL PLUG SYSTEM
K021936 · Moist Medical, Inc. · Oct 2002
SHARPOINT ULTRAPLUG EXTENDED WEAR PLUG
K020882 · Surgical Specialties Corp · Jul 2002
K030300 · OPAQUE HERRICK LACRIMAL PLUG
Download PDF FDA Summary Lacrimedics, Inc.