Cleared Traditional

VISALENS CONCENTRATED CLEANER CONT LENS (K791524) - FDA 510(k) Clearance

K791524 · Pfizer, Inc. · Ophthalmic device
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Nov 1979
Decision
102d
Days
-
Risk

K791524 is an FDA 510(k) clearance for the VISALENS CONCENTRATED CLEANER CONT LENS. Classified as Lens, Contact (polymethylmethacrylate) (product code HPX).

Submitted by Pfizer, Inc. (Walker, US). The FDA issued a Cleared decision on November 20, 1979 after a review of 102 days - within the typical 510(k) review window.

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 K791524 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 1979
Decision Date November 20, 1979
Days to Decision 102 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
8d faster than avg
Panel avg: 110d · This submission: 102d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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