Cleared Traditional

K043183 - EPI-K (FDA 510(k) Clearance)

Class I Ophthalmic device.

K043183 · Moria SA · Ophthalmic device
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Mar 2005
Decision
128d
Days
Class 1
Risk

K043183 is an FDA 510(k) clearance for the EPI-K. Classified as Keratome, Ac-powered (product code HNO), Class I - General Controls.

Submitted by Moria SA (Antony, FR). The FDA issued a Cleared decision on March 25, 2005 after a review of 128 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4370 - the FDA ophthalmic device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K043183 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 17, 2004
Decision Date March 25, 2005
Days to Decision 128 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
18d slower than avg
Panel avg: 110d · This submission: 128d
Pathway characteristics
Predicate-based equivalence.

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.