Cleared Traditional

BIO-COR EXT COLLAGEN CORNEAL SHIELD (K874225) - FDA 510(k) Clearance

Class I Ophthalmic device.

K874225 · Bausch & Lomb, Inc. · Ophthalmic device
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Jan 1988
Decision
98d
Days
Class 1
Risk

K874225 is an FDA 510(k) clearance for the BIO-COR EXT COLLAGEN CORNEAL SHIELD. Classified as Collagen Corneal Shield (product code MOE), Class I - General Controls.

Submitted by Bausch & Lomb, Inc. (Clearwater, US). The FDA issued a Cleared decision on January 22, 1988 after a review of 98 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.

View all Bausch & Lomb, Inc. devices

Submission Details

510(k) Number K874225 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 16, 1987
Decision Date January 22, 1988
Days to Decision 98 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
12d faster than avg
Panel avg: 110d · This submission: 98d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MOE Collagen Corneal Shield
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.