Cleared Traditional

PUNCTUM PLUGS & READY-SET PUNCTAL PLUGS (K964774) - FDA 510(k) Clearance

K964774 · Fci Ophthalmics, Inc. · Ophthalmic device
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Dec 1996
Decision
59d
Days
-
Risk

K964774 is an FDA 510(k) clearance for the PUNCTUM PLUGS & READY-SET PUNCTAL PLUGS. Classified as Plug, Punctum (product code LZU).

Submitted by Fci Ophthalmics, Inc. (Marshfield Hills, US). The FDA issued a Cleared decision on December 20, 1996 after a review of 59 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Fci Ophthalmics, Inc. devices

Submission Details

510(k) Number K964774 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 22, 1996
Decision Date December 20, 1996
Days to Decision 59 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
51d faster than avg
Panel avg: 110d · This submission: 59d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LZU Plug, Punctum
Device Class -