Cleared Traditional

LENSES, CONTACT, POLYMETHYL METHACRYLATE (K760213) - FDA 510(k) Clearance

K760213 · Progressive Affiliated Labs, Inc. · Ophthalmic device
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Aug 1976
Decision
28d
Days
-
Risk

K760213 is an FDA 510(k) clearance for the LENSES, CONTACT, POLYMETHYL METHACRYLATE. Classified as Lens, Contact (polymethylmethacrylate) (product code HPX).

Submitted by Progressive Affiliated Labs, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 9, 1976 after a review of 28 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 Progressive Affiliated Labs, Inc. devices

Submission Details

510(k) Number K760213 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 12, 1976
Decision Date August 09, 1976
Days to Decision 28 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
82d faster than avg
Panel avg: 110d · This submission: 28d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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