Cleared Special

K032978 - MODIFICATION TO CIBA VISION CENTURION SES SPIKERATOME (FDA 510(k) Clearance)

Class I Ophthalmic device.

K032978 · Ciba Vision Corporation · Ophthalmic device
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Oct 2003
Decision
26d
Days
Class 1
Risk

K032978 is an FDA 510(k) clearance for the MODIFICATION TO CIBA VISION CENTURION SES SPIKERATOME. Classified as Keratome, Ac-powered (product code HNO), Class I - General Controls.

Submitted by Ciba Vision Corporation (Duluth, US). The FDA issued a Cleared decision on October 20, 2003 after a review of 26 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4370 - the FDA ophthalmic device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Ciba Vision Corporation devices

Submission Details

510(k) Number K032978 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 2003
Decision Date October 20, 2003
Days to Decision 26 days
Submission Type Special
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
84d faster than avg
Panel avg: 110d · This submission: 26d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code HNO Keratome, Ac-powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.4370
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.