Cleared Traditional

K896681 - SOFT CORNEAL LIGHT SHIELD

K896681 is an FDA 510(k) clearance for SOFT CORNEAL LIGHT SHIELD, manufactured by Visitec Co.. The device is a Class 1 Ophthalmic device with product code HOY cleared through the Traditional 510(k) pathway after a 45-day FDA review.

K896681 · Visitec Co. · Ophthalmic device
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Jan 1990
Decision
45d
Days
Class 1
Risk

K896681 is an FDA 510(k) clearance for the SOFT 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 Visitec Co. (Sarasota, US). The FDA issued a Cleared decision on January 11, 1990 after a review of 45 days - a notably fast clearance 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: 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 Visitec Co. devices

FDA 510(k) Submission Details - K896681

510(k) Number K896681 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 27, 1989
Decision Date January 11, 1990
Days to Decision 45 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
65d faster than avg
Panel avg: 110d · This submission: 45d
Pathway characteristics
Predicate-based equivalence.

HOY Device Classification - Class 1, General Controls

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 9
Devices cleared under the same product code (HOY) and FDA review panel - the closest regulatory comparables to K896681.
SHAIDS PROTECTIVE GLASSES
K930347 · Depuy, Inc. · Apr 1994
EYE BUBBLE
K912367 · Aaron Medical Industries · Oct 1991
UNIDIRECTIONAL OCCLUDER
K913230 · Welch Allyn, Inc. · Oct 1991
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