Cleared Traditional

K822105 - LENS EASY ON

K822105 · L.E.O. Corp. · Ophthalmic device

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Aug 1982

Decision

31d

Days

Risk

K822105 is an FDA 510(k) clearance for the LENS EASY ON. Classified as Lens, Contact (polymethylmethacrylate) (product code HPX).

Submitted by L.E.O. Corp. (Mchenry, US). The FDA issued a Cleared decision on August 20, 1982 after a review of 31 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 L.E.O. Corp. devices

Submission Details

510(k) Number	K822105 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	July 20, 1982
Decision Date	August 20, 1982
Days to Decision	31 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	-
Third-party Review	No - reviewed directly by FDA

Regulatory Context

Review time vs. panel average

79d faster than avg

Panel avg: 110d · This submission: 31d

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 K822105.

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 K822105

L.E.O. Corp.

Mchenry, IL · US

Regulatory profile

1 submissions 1 cleared

100% clearance rate · Active in Ophthalmic

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

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