Cleared Traditional

K800192 - DURALITE LENS (FDA 510(k) Clearance)

K800192 · American Optical Corp. · Ophthalmic device
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Mar 1980
Decision
43d
Days
-
Risk

K800192 is an FDA 510(k) clearance for the DURALITE LENS. Classified as Lens, Contact (polymethylmethacrylate) (product code HPX).

Submitted by American Optical Corp. (Mchenry, US). The FDA issued a Cleared decision on March 12, 1980 after a review of 43 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all American Optical Corp. devices

Submission Details

510(k) Number K800192 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 29, 1980
Decision Date March 12, 1980
Days to Decision 43 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
67d faster than avg
Panel avg: 110d · This submission: 43d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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