Cleared Traditional

K880489 - CLEAR EYE GARTER SHIELD

K880489 is the FDA 510(k) clearance for CLEAR EYE GARTER SHIELD by Eye Garter Company, Inc.. It is a Class 1 Ophthalmic device (product code HOY) cleared through the Traditional 510(k) pathway after a 186-day FDA review.

K880489 · Eye Garter Company, Inc. · Ophthalmic device
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Aug 1988
Decision
186d
Days
Class 1
Risk

K880489 is an FDA 510(k) clearance for the CLEAR EYE GARTER SHIELD. Classified as Shield, Eye, Ophthalmic (including Sunlamp Protective Eyewear And Post-mydriatic Eyewear) (product code HOY), Class I - General Controls.

Submitted by Eye Garter Company, Inc. (Houston, US). The FDA issued a Cleared decision on August 8, 1988 after a review of 186 days - an extended review cycle.

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.

View all Eye Garter Company, Inc. devices

Submission Details

510(k) Number K880489 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 04, 1988
Decision Date August 08, 1988
Days to Decision 186 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
76d slower than avg
Panel avg: 110d · This submission: 186d
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.

Regulatory Peers - HOY Shield, Eye, Ophthalmic (including Sunlamp Protective Eyewear And Post-mydriatic Eyewear)

All 10
Devices cleared under the same product code (HOY) and FDA review panel - the closest regulatory comparables to K880489.
EYE BUBBLE
K912367 · Aaron Medical Industries · Oct 1991
UNIDIRECTIONAL OCCLUDER
K913230 · Welch Allyn, Inc. · Oct 1991
SOFT CORNEAL LIGHT SHIELD
K896681 · Visitec Co. · Jan 1990
HEALTH CARE EYE PROTECTION
K875107 · Surgikos, Inc. · Mar 1988
EYE GARD
K872000 · Treace Medical, Inc. · Jul 1987
HESSBURG LIGHT GUARD
K853035 · Visitec Co. · Dec 1985