Cleared Traditional

ONEUSE- PLUS MICROKERATOME

K040297 · Moria SA · Ophthalmic
Mar 2004
Decision
51d
Days
Class 1
Risk

About This 510(k) Submission

K040297 is an FDA 510(k) clearance for the ONEUSE- PLUS MICROKERATOME, a Keratome, Battery-powered (Class I — General Controls, product code HMY), submitted by Moria SA (Antony, FR). The FDA issued a Cleared decision on March 31, 2004, 51 days after receiving the submission on February 9, 2004. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4370.

Submission Details

510(k) Number K040297 FDA.gov
FDA Decision Cleared SESE
Date Received February 09, 2004
Decision Date March 31, 2004
Days to Decision 51 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

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

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