Cleared Traditional

ULTRAVIOLET LIGHT PROTECTVE EYEWERE (K880666) - FDA 510(k) Clearance

Class I Ophthalmic device.

K880666 · Free Sun Intl. AB · Ophthalmic device
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Jun 1988
Decision
131d
Days
Class 1
Risk

K880666 is an FDA 510(k) clearance for the ULTRAVIOLET LIGHT PROTECTVE EYEWERE. Classified as Shield, Eye, Ophthalmic (including Sunlamp Protective Eyewear And Post-mydriatic Eyewear) (product code HOY), Class I - General Controls.

Submitted by Free Sun Intl. AB (Reseda, US). The FDA issued a Cleared decision on June 28, 1988 after a review of 131 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4750 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K880666 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 18, 1988
Decision Date June 28, 1988
Days to Decision 131 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
21d slower than avg
Panel avg: 110d · This submission: 131d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HOY Shield, Eye, Ophthalmic (including Sunlamp Protective Eyewear And Post-mydriatic Eyewear)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.4750
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.