Cleared Traditional

K840834 - CORNEAL LIGHT SHIELD

K840834 is the FDA 510(k) clearance for CORNEAL LIGHT SHIELD by Gabl, Inc.. It is a Class 1 Ophthalmic device (product code HOY) cleared through the Traditional 510(k) pathway after a 224-day FDA review.

K840834 · Gabl, Inc. · Ophthalmic device
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Oct 1984
Decision
224d
Days
Class 1
Risk

K840834 is an FDA 510(k) clearance for the CORNEAL LIGHT SHIELD. Classified as Shield, Eye, Ophthalmic (including Sunlamp Protective Eyewear And Post-mydriatic Eyewear) (product code HOY), Class I - General Controls.

Submitted by Gabl, Inc. (Walker, US). The FDA issued a Cleared decision on October 5, 1984 after a review of 224 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 Gabl, Inc. devices

Submission Details

510(k) Number K840834 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 24, 1984
Decision Date October 05, 1984
Days to Decision 224 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
114d slower than avg
Panel avg: 110d · This submission: 224d
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 K840834.
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
STORZ UNIVERSAL EYE SHIELD
K841599 · Storz Instrument Co. · May 1984
NEONATE MASK FOR BABIES
K840444 · Richards Medical Co., Inc. · Mar 1984
FOX EYE SHIELDS
K810098 · American Hospital Supply Corp. · Feb 1981