Cleared Traditional

KERATOPLASTY SUTURING LENS (K802593) - FDA 510(k) Clearance

K802593 · Paris Contact Lens Laboratory · Ophthalmic device
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Dec 1980
Decision
62d
Days
-
Risk

K802593 is an FDA 510(k) clearance for the KERATOPLASTY SUTURING LENS. Classified as Lens, Contact (polymethylmethacrylate) (product code HPX).

Submitted by Paris Contact Lens Laboratory (Mchenry, US). The FDA issued a Cleared decision on December 22, 1980 after a review of 62 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 K802593 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 21, 1980
Decision Date December 22, 1980
Days to Decision 62 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
48d faster than avg
Panel avg: 110d · This submission: 62d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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