Cleared Traditional

PY-RITE (K853758) - FDA 510(k) Clearance

Class I Ophthalmic device.

K853758 · Golden Dental Products, Inc. · Ophthalmic device
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Dec 1985
Decision
85d
Days
Class 1
Risk

K853758 is an FDA 510(k) clearance for the PY-RITE. Classified as Lens, Spectacle (prescription), For Reading Discomfort (product code NJH), Class I - General Controls.

Submitted by Golden Dental Products, Inc. (Golden, US). The FDA issued a Cleared decision on December 3, 1985 after a review of 85 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.5844 - the FDA ophthalmic device framework. 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 Golden Dental Products, Inc. devices

Submission Details

510(k) Number K853758 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 1985
Decision Date December 03, 1985
Days to Decision 85 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
25d faster than avg
Panel avg: 110d · This submission: 85d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code NJH Lens, Spectacle (prescription), For Reading Discomfort
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.5844
Definition Colored Spectacle Lenses May Also Be Prescribed As A Colored Filter To Aid Individuals Who Experience Reading Discomfort Not Related To Binocular Vision Problems Or Uncorrected Refractive Error.
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.