Cleared Traditional

K040297 - ONEUSE- PLUS MICROKERATOME (FDA 510(k) Clearance)

Class I Ophthalmic device.

K040297 · Moria SA · Ophthalmic device
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Optimized for regulatory review, auditing and printing
Mar 2004
Decision
51d
Days
Class 1
Risk

K040297 is an FDA 510(k) clearance for the ONEUSE- PLUS MICROKERATOME. Classified as Keratome, Battery-powered (product code HMY), Class I - General Controls.

Submitted by Moria SA (Antony, FR). The FDA issued a Cleared decision on March 31, 2004 after a review of 51 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Moria SA devices

Submission Details

510(k) Number K040297 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
59d faster than avg
Panel avg: 110d · This submission: 51d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HMY Keratome, Battery-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.