Cleared Traditional

K802593 - KERATOPLASTY SUTURING LENS

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.

FDA 510(k) Submission Details - K802593

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.

HPX Device Classification - Class 0,

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

Regulatory Peers - HPX Lens, Contact (polymethylmethacrylate)

All 72
Devices cleared under the same product code (HPX) and FDA review panel - the closest regulatory comparables to K802593.
BARNES-HIND WEEKLY CLEANER
K812135 · Barnes-Hind, Inc. · Aug 1981
CONTACT LENS CLEANER
K812172 · Alcon Laboratories · Aug 1981
OPTOCRYL CONTACT LENS BLANKS
K810130 · Optacryl, Inc. · Jun 1981
DURALITE LENS
K800192 · American Optical Corp. · Mar 1980
VISALENS ALL PURPOSE SOLUTION FOR LENS
K791523 · Pfizer, Inc. · Feb 1980
CONTACT LENSES MADE OF POLYMETHYLMETHACR
K792224 · Contact Lenses of the Pacific, Inc. · Dec 1979
K802593 · KERATOPLASTY SUTURING LENS
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