Cleared Traditional

K822495 - LE CASE HARD CONTACT LENS STORAGE CASE

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	-

Regulatory Peers - HPX Lens, Contact (polymethylmethacrylate)

All 19

Devices cleared under the same product code (HPX) and FDA review panel - the closest regulatory comparables to K822495.

CLERZ LUBRICATING & REWETTING EYE DROPS

K830740 · CooperVision, Inc. · Jun 1983

PRE-SERT

K822706 · Allergan, Inc. · Oct 1982

CLEAN-N-SOAK

K822707 · Allergan, Inc. · Oct 1982

LIQUIFILM WETTING SOLUTION

K821051 · Allergan, Inc. · May 1982

SOAKARE

K821052 · Allergan, Inc. · May 1982

TOTAL

K821054 · Allergan, Inc. · May 1982

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K822495

Optikem International, Inc.

Walker, MI · US

Regulatory profile

2 submissions 2 cleared

100% clearance rate · Active in Ophthalmic

Data Intelligence Layer

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Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . Updated monthly.

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