Cleared Special

NORWOOD ABBEY CENTURION SES EPIKERATOME (K051486) - FDA 510(k) Clearance

Class I Ophthalmic device.

K051486 · Norwood Abbey , Ltd. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2005
Decision
30d
Days
Class 1
Risk

K051486 is an FDA 510(k) clearance for the NORWOOD ABBEY 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 July 6, 2005 after a review of 30 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 Norwood Abbey , Ltd. devices

Submission Details

510(k) Number K051486 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 06, 2005
Decision Date July 06, 2005
Days to Decision 30 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
80d faster than avg
Panel avg: 110d · This submission: 30d
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.