Cleared Traditional

K760213 - LENSES, CONTACT, POLYMETHYL METHACRYLATE

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.

FDA 510(k) Submission Details - K760213

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.

HPX Device Classification - Class 0,

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

Regulatory Peers - HPX Lens, Contact (polymethylmethacrylate)

All 71
Devices cleared under the same product code (HPX) and FDA review panel - the closest regulatory comparables to K760213.
AUTO-CON
K781007 · Barnes-Hind, Inc. · Jun 1978
LENS, CONTACT, HARD
K770582 · Berea Contact Lens, Inc. · May 1977
CASE, CONTACT LENS, PLASTIC
K760046 · Tomlin B. Horsley, Jr. · Oct 1976
BUTTONS, PMMA (FOR CONTACT LENSES)
K760204 · Burton Parsons & Co., Inc. · Aug 1976
LENS, HARD CONTACT
K760126 · Tru-Form Optics, Inc. · Jul 1976
K760213 · LENSES, CONTACT, POLYMETHYL METHACRYLATE
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