Cleared Special

EPI K Console

K172994 · Moria SA · Ophthalmic
Oct 2017
Decision
29d
Days
Class 1
Risk

About This 510(k) Submission

K172994 is an FDA 510(k) clearance for the EPI K Console, a Keratome, Ac-powered (Class I — General Controls, product code HNO), submitted by Moria SA (Antony, FR). The FDA issued a Cleared decision on October 26, 2017, 29 days after receiving the submission on September 27, 2017. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4370.

Submission Details

510(k) Number K172994 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code HNO — Keratome, Ac-powered
Device Class Class I — General Controls
CFR Regulation 21 CFR 886.4370

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