Cleared Special

K032978 - MODIFICATION TO CIBA VISION CENTURION SES SPIKERATOME

K032978 is an FDA 510(k) clearance for MODIFICATION TO CIBA VISION CENTURION S..., manufactured by Ciba Vision Corporation. The device is a Class 1 Ophthalmic device with product code HNO cleared through the Special 510(k) pathway after a 26-day FDA review.

K032978 · Ciba Vision Corporation · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K032978

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
84d faster than avg
Panel avg: 110d · This submission: 26d
Pathway characteristics
Modification to existing cleared device.

HNO Device Classification - Class 1, General Controls

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.

Regulatory Peers - HNO Keratome, Ac-powered

All 82
Devices cleared under the same product code (HNO) and FDA review panel - the closest regulatory comparables to K032978.
ZYOPTIX XP MICROKERATOME
K040204 · Bausch & Lomb, Inc. · Mar 2004
PRIZM KERATOME BLADE (B.D. MODEL), MODEL MK8530BD
K033182 · Surgin Surgical Instrumentation, Inc. · Jan 2004
MED-LOGICS, MODEL ML7090
K033293 · Med-Logics, Inc. · Jan 2004
DISPOSABLE N-PE MICKROKERATOME BLADES
K032297 · Oasis Medical, Inc. · Aug 2003
CENTURION SES EPIKERATOME
K031735 · Ciba Vision Corporation · Aug 2003
DISPOSABLE M2-PE MICROKERATOME BLADES
K030401 · Oasis Medical, Inc. · Jun 2003
K032978 · MODIFICATION TO CIBA VISION CENTURION SES SPIKERATOME
Download PDF FDA Summary Ciba Vision Corporati…