Cleared Traditional

MEDILENS(TM) CORNEAL SHIELD (K901880) - FDA 510(k) Clearance

Class I Ophthalmic device.

K901880 · Chiron Ophthalmics · Ophthalmic device
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Jul 1990
Decision
67d
Days
Class 1
Risk

K901880 is an FDA 510(k) clearance for the MEDILENS(TM) CORNEAL SHIELD. Classified as Collagen Corneal Shield (product code MOE), Class I - General Controls.

Submitted by Chiron Ophthalmics (Irvine, US). The FDA issued a Cleared decision on July 2, 1990 after a review of 67 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 Chiron Ophthalmics devices

Submission Details

510(k) Number K901880 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 1990
Decision Date July 02, 1990
Days to Decision 67 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
43d faster than avg
Panel avg: 110d · This submission: 67d
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.