Cleared Traditional

OPTIKEM PMMA CONTACT LENS (K895411) - FDA 510(k) Clearance

K895411 · Optikem Polymers, Inc. · Ophthalmic device
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Optimized for regulatory review, auditing and printing
Feb 1990
Decision
174d
Days
-
Risk

K895411 is an FDA 510(k) clearance for the OPTIKEM PMMA CONTACT LENS. Classified as Lens, Contact (polymethylmethacrylate) (product code HPX).

Submitted by Optikem Polymers, Inc. (Englewood, US). The FDA issued a Cleared decision on February 27, 1990 after a review of 174 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.

View all Optikem Polymers, Inc. devices

Submission Details

510(k) Number K895411 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 1989
Decision Date February 27, 1990
Days to Decision 174 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
64d slower than avg
Panel avg: 110d · This submission: 174d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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