Cleared Traditional

K140352 - VERAPLUG (FDA 510(k) Clearance)

K140352 · Krishna Imports Inc Dba Stephens Instruments · Ophthalmic device
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Nov 2014
Decision
274d
Days
-
Risk

K140352 is an FDA 510(k) clearance for the VERAPLUG. Classified as Plug, Punctum (product code LZU).

Submitted by Krishna Imports Inc Dba Stephens Instruments (Lexington, US). The FDA issued a Cleared decision on November 13, 2014 after a review of 274 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 K140352 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 12, 2014
Decision Date November 13, 2014
Days to Decision 274 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
164d slower than avg
Panel avg: 110d · This submission: 274d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LZU Plug, Punctum
Device Class -