Cleared Traditional

ADDIT. INDICATIONS FOR BIO-COR EXT COLLAGEN CORNEA (K884962) - FDA 510(k) Clearance

Class I Ophthalmic device.

K884962 · Bausch & Lomb Pharmaceutical, Inc. · Ophthalmic device
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Feb 1990
Decision
448d
Days
Class 1
Risk

K884962 is an FDA 510(k) clearance for the ADDIT. INDICATIONS FOR BIO-COR EXT COLLAGEN CORNEA. Classified as Collagen Corneal Shield (product code MOE), Class I - General Controls.

Submitted by Bausch & Lomb Pharmaceutical, Inc. (Clearwater, US). The FDA issued a Cleared decision on February 9, 1990 after a review of 448 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Ophthalmic submissions.

View all Bausch & Lomb Pharmaceutical, Inc. devices

Submission Details

510(k) Number K884962 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 18, 1988
Decision Date February 09, 1990
Days to Decision 448 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
338d slower than avg
Panel avg: 110d · This submission: 448d
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.