Cleared Special

K043150 - AMADEUS II EPIKERATOME

K043150 is an FDA 510(k) clearance for AMADEUS II EPIKERATOME, manufactured by Sis Ltd., Surgical Instrument Systems. The device is a Class 1 Ophthalmic device with product code HNO cleared through the Special 510(k) pathway after a 77-day FDA review.

K043150 · Sis Ltd., Surgical Instrument Systems · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2005
Decision
77d
Days
Class 1
Risk

K043150 is an FDA 510(k) clearance for the AMADEUS II EPIKERATOME. Classified as Keratome, Ac-powered (product code HNO), Class I - General Controls.

Submitted by Sis Ltd., Surgical Instrument Systems (Littleton, US). The FDA issued a Cleared decision on January 31, 2005 after a review of 77 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 - K043150

510(k) Number K043150 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 15, 2004
Decision Date January 31, 2005
Days to Decision 77 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
33d faster than avg
Panel avg: 110d · This submission: 77d
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 K043150.
HORIZON EPIKERATOME DISPOSABLE MICROKERATOME SYSTEM
K052891 · Hawken Industries · Mar 2006
NORWOOD ABBEY CENTURION SES EPIKERATOME
K051486 · Norwood Abbey , Ltd. · Jul 2005
EPI-K
K043183 · Moria SA · Mar 2005
MODIFICATION TO VISITOME 20-10 MICROKERATOME
K042083 · Biovision AG · Nov 2004
CENTURION SES EPIKERATOME
K042810 · Norwood Abbey , Ltd. · Oct 2004
MB 105 MILLENNIUM BLADES
K041110 · Millennium Biomedical, Inc. · Oct 2004
K043150 · AMADEUS II EPIKERATOME
Download PDF FDA Summary Sis Ltd., Surgical In…