Cleared Traditional

EAGLE VISION FREEMAN RADIOPAGUE PUNCTUM PLUG (K905427) - FDA 510(k) Clearance

K905427 · Eagle Vision, Inc. · Ophthalmic device
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Jun 1991
Decision
184d
Days
-
Risk

K905427 is an FDA 510(k) clearance for the EAGLE VISION FREEMAN RADIOPAGUE PUNCTUM PLUG. Classified as Plug, Punctum (product code LZU).

Submitted by Eagle Vision, Inc. (Bethesda, US). The FDA issued a Cleared decision on June 6, 1991 after a review of 184 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 Eagle Vision, Inc. devices

Submission Details

510(k) Number K905427 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 1990
Decision Date June 06, 1991
Days to Decision 184 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
74d slower than avg
Panel avg: 110d · This submission: 184d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LZU Plug, Punctum
Device Class -