Cleared Traditional

EAGLEVISION GELLANSERTS, MODEL REF 0040 (K053333) - FDA 510(k) Clearance

K053333 · Eagle Vision, Inc. · Ophthalmic device
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Optimized for regulatory review, auditing and printing
May 2006
Decision
152d
Days
-
Risk

K053333 is an FDA 510(k) clearance for the EAGLEVISION GELLANSERTS, MODEL REF 0040. Classified as Plug, Punctum (product code LZU).

Submitted by Eagle Vision, Inc. (Memphis, US). The FDA issued a Cleared decision on May 2, 2006 after a review of 152 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.

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Submission Details

510(k) Number K053333 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 2005
Decision Date May 02, 2006
Days to Decision 152 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
42d slower than avg
Panel avg: 110d · This submission: 152d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LZU Plug, Punctum
Device Class -