Cleared Traditional

K883489 - KRATZ NOVA SERT(TM) (FDA 510(k) Clearance)

Class I Ophthalmic device.

K883489 · Coopervision-Cilco · Ophthalmic device
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Oct 1988
Decision
70d
Days
Class 1
Risk

K883489 is an FDA 510(k) clearance for the KRATZ NOVA SERT(TM). Classified as Lens, Guide, Intraocular (product code KYB), Class I - General Controls.

Submitted by Coopervision-Cilco (Bellevue, US). The FDA issued a Cleared decision on October 25, 1988 after a review of 70 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4300 - 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 Coopervision-Cilco devices

Submission Details

510(k) Number K883489 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 16, 1988
Decision Date October 25, 1988
Days to Decision 70 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 110d · This submission: 70d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KYB Lens, Guide, Intraocular
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.4300
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.