Cleared Traditional

K895411 - OPTIKEM PMMA CONTACT LENS

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

FDA 510(k) Submission Details - K895411

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.

HPX Device Classification - Class 0,

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

Regulatory Peers - HPX Lens, Contact (polymethylmethacrylate)

All 20
Devices cleared under the same product code (HPX) and FDA review panel - the closest regulatory comparables to K895411.
PMMA CLASIC
K955777 · Rand Scientific Corp. · May 1996
STYLEKEEPER CONTACT LENS CARRYING CASE
K861643 · Allergan, Inc. · Jun 1986
LENSKEEPER CONTACT LENS CARRYING CASE
K861642 · Allergan, Inc. · May 1986
BAUSCH & LOMB LENS CARRYING CASE
K854968 · Bausch & Lomb, Inc. · Apr 1986
SIGHT SAVER ALL PURPOSE LENS CARRYING CASE
K852384 · Bausch & Lomb, Inc. · Jul 1985
SENSITIVE EYES
K832706 · Bausch & Lomb, Inc. · Oct 1983