Cleared Traditional

LE CASE HARD CONTACT LENS STORAGE CASE (K822495) - FDA 510(k) Clearance

K822495 · Optikem International, Inc. · Ophthalmic device
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Sep 1982
Decision
43d
Days
-
Risk

K822495 is an FDA 510(k) clearance for the LE CASE HARD CONTACT LENS STORAGE CASE. Classified as Lens, Contact (polymethylmethacrylate) (product code HPX).

Submitted by Optikem International, Inc. (Walker, US). The FDA issued a Cleared decision on September 30, 1982 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 Optikem International, Inc. devices

Submission Details

510(k) Number K822495 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 18, 1982
Decision Date September 30, 1982
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 -