Cleared Traditional

DURALITE LENS

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

About This 510(k) Submission

K800192 is an FDA 510(k) clearance for the DURALITE LENS, a Lens, Contact (polymethylmethacrylate), submitted by American Optical Corp. (Mchenry, US). The FDA issued a Cleared decision on March 12, 1980, 43 days after receiving the submission on January 29, 1980. This device falls under the Ophthalmic review panel.

Submission Details

510(k) Number K800192 FDA.gov
FDA Decision Cleared SESE
Date Received January 29, 1980
Decision Date March 12, 1980
Days to Decision 43 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary —

Device Classification

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

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