Cleared Traditional

CONTACT LENSES MADE OF POLYMETHYLMETHACR (K792224) - FDA 510(k) Clearance

K792224 · Contact Lenses of the Pacific, Inc. · Ophthalmic device
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Dec 1979
Decision
36d
Days
-
Risk

K792224 is an FDA 510(k) clearance for the CONTACT LENSES MADE OF POLYMETHYLMETHACR. Classified as Lens, Contact (polymethylmethacrylate) (product code HPX).

Submitted by Contact Lenses of the Pacific, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 11, 1979 after a review of 36 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 Contact Lenses of the Pacific, Inc. devices

Submission Details

510(k) Number K792224 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 05, 1979
Decision Date December 11, 1979
Days to Decision 36 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
74d faster than avg
Panel avg: 110d · This submission: 36d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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