Cleared Traditional

SPECTACLE FRAMES (K933991) - FDA 510(k) Clearance

Class I Ophthalmic device.

K933991 · U.S. Optical · Ophthalmic device
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Oct 1993
Decision
62d
Days
Class 1
Risk

K933991 is an FDA 510(k) clearance for the SPECTACLE FRAMES. Classified as Frame, Spectacle (product code HQZ), Class I - General Controls.

Submitted by U.S. Optical (Miami, US). The FDA issued a Cleared decision on October 18, 1993 after a review of 62 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.5842 - 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.

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Submission Details

510(k) Number K933991 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 17, 1993
Decision Date October 18, 1993
Days to Decision 62 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement
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.

Device Classification

Product Code HQZ Frame, Spectacle
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.5842
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.