Cleared Traditional

LENS EASY ON (K822105) - FDA 510(k) Clearance

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.

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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 -