Cleared Traditional

VISALENS ALL PURPOSE SOLUTION FOR LENS (K791523) - FDA 510(k) Clearance

K791523 · Pfizer, Inc. · Ophthalmic device
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Feb 1980
Decision
193d
Days
-
Risk

K791523 is an FDA 510(k) clearance for the VISALENS ALL PURPOSE SOLUTION FOR LENS. Classified as Lens, Contact (polymethylmethacrylate) (product code HPX).

Submitted by Pfizer, Inc. (Walker, US). The FDA issued a Cleared decision on February 19, 1980 after a review of 193 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 K791523 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 1979
Decision Date February 19, 1980
Days to Decision 193 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
83d slower than avg
Panel avg: 110d · This submission: 193d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HPX Lens, Contact (polymethylmethacrylate)
Device Class -