Cleared Traditional

SPECTABLE FRAME - PRODESIGN SUN CLUB (K844658) - FDA 510(k) Clearance

Class I Ophthalmic device.

K844658 · Pro Design Intl. AS · Ophthalmic device
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Dec 1984
Decision
12d
Days
Class 1
Risk

K844658 is an FDA 510(k) clearance for the SPECTABLE FRAME - PRODESIGN SUN CLUB. Classified as Frame, Spectacle (product code HQZ), Class I - General Controls.

Submitted by Pro Design Intl. AS (New York, US). The FDA issued a Cleared decision on December 11, 1984 after a review of 12 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 Pro Design Intl. AS devices

Submission Details

510(k) Number K844658 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 29, 1984
Decision Date December 11, 1984
Days to Decision 12 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
98d faster than avg
Panel avg: 110d · This submission: 12d
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.