Cleared Special

K042810 - CENTURION SES EPIKERATOME

K042810 is an FDA 510(k) clearance for CENTURION SES EPIKERATOME, manufactured by Norwood Abbey , Ltd.. The device is a Class 1 Ophthalmic device with product code HNO cleared through the Special 510(k) pathway after a 16-day FDA review.

K042810 · Norwood Abbey , Ltd. · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2004
Decision
16d
Days
Class 1
Risk

K042810 is an FDA 510(k) clearance for the CENTURION SES EPIKERATOME. Classified as Keratome, Ac-powered (product code HNO), Class I - General Controls.

Submitted by Norwood Abbey , Ltd. (Chelsea Hgts., Victoria, AU). The FDA issued a Cleared decision on October 28, 2004 after a review of 16 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 - K042810

510(k) Number K042810 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 12, 2004
Decision Date October 28, 2004
Days to Decision 16 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
94d faster than avg
Panel avg: 110d · This submission: 16d
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 K042810.
EPI-K
K043183 · Moria SA · Mar 2005
AMADEUS II EPIKERATOME
K043150 · Sis Ltd., Surgical Instrument Systems · Jan 2005
MODIFICATION TO VISITOME 20-10 MICROKERATOME
K042083 · Biovision AG · Nov 2004
MB 105 MILLENNIUM BLADES
K041110 · Millennium Biomedical, Inc. · Oct 2004
EPITOME SYSTEM
K041206 · Gebauer Medizintechnik GmbH · Sep 2004
CARRIAZO PENDULAR
K032910 · Schwind Eye-Tech-Solutions GmbH & Co. KG · Aug 2004
K042810 · CENTURION SES EPIKERATOME
Download PDF FDA Summary Norwood Abbey , Ltd.