Cleared Traditional

FRAMES (SPECTACLES) (K914239) - FDA 510(k) Clearance

Class I Ophthalmic device.

K914239 · Jane Fui Optical Co., Ltd. · Ophthalmic device
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Dec 1991
Decision
89d
Days
Class 1
Risk

K914239 is an FDA 510(k) clearance for the FRAMES (SPECTACLES). Classified as Frame, Spectacle (product code HQZ), Class I - General Controls.

Submitted by Jane Fui Optical Co., Ltd. (Dallas, US). The FDA issued a Cleared decision on December 16, 1991 after a review of 89 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.

View all Jane Fui Optical Co., Ltd. devices

Submission Details

510(k) Number K914239 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 18, 1991
Decision Date December 16, 1991
Days to Decision 89 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
21d faster than avg
Panel avg: 110d · This submission: 89d
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.