Cleared Traditional

K963501 - HERRICK ULTIMATE PUNCTUM PLUG (FDA 510(k) Clearance)

K963501 · Lacrimedics, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1997
Decision
223d
Days
-
Risk

K963501 is an FDA 510(k) clearance for the HERRICK ULTIMATE PUNCTUM PLUG. Classified as Plug, Punctum (product code LZU).

Submitted by Lacrimedics, Inc. (Rialto, US). The FDA issued a Cleared decision on April 14, 1997 after a review of 223 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.

View all Lacrimedics, Inc. devices

Submission Details

510(k) Number K963501 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 1996
Decision Date April 14, 1997
Days to Decision 223 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
113d slower than avg
Panel avg: 110d · This submission: 223d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LZU Plug, Punctum
Device Class -