Cleared Special

K172994 - EPI K Console (FDA 510(k) Clearance)

Class I Ophthalmic device.

K172994 · Moria SA · Ophthalmic device
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Optimized for regulatory review, auditing and printing
Oct 2017
Decision
29d
Days
Class 1
Risk

K172994 is an FDA 510(k) clearance for the EPI K Console. 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 October 26, 2017 after a review of 29 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 Moria SA devices

Submission Details

510(k) Number K172994 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 2017
Decision Date October 26, 2017
Days to Decision 29 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
81d faster than avg
Panel avg: 110d · This submission: 29d
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.