Cleared Traditional

K022560 - M2 SINGLE USE MICROKERTOME

K022560 is an FDA 510(k) clearance for M2 SINGLE USE MICROKERTOME, manufactured by Moria SA. The device is a Class 1 Ophthalmic device with product code HMY cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K022560 · Moria SA · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2002
Decision
56d
Days
Class 1
Risk

K022560 is an FDA 510(k) clearance for the M2 SINGLE USE MICROKERTOME. 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 September 27, 2002 after a review of 56 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.

FDA 510(k) Submission Details - K022560

510(k) Number K022560 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 02, 2002
Decision Date September 27, 2002
Days to Decision 56 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
54d faster than avg
Panel avg: 110d · This submission: 56d
Pathway characteristics
Predicate-based equivalence.

HMY Device Classification - Class 1, General Controls

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.

Regulatory Peers - HMY Keratome, Battery-powered

All 11
Devices cleared under the same product code (HMY) and FDA review panel - the closest regulatory comparables to K022560.
ONEUSE- PLUS MICROKERATOME
K040297 · Moria SA · Mar 2004
BD K-4000 MICROKERATOME SYSTEM
K023092 · Becton, Dickinson & CO · Oct 2002
BD-3000 MICROKERATOME SYSTEM, MODEL K-3000 MICROKERATOME
K022637 · Becton, Dickinson & CO · Oct 2002
CARRIAZO BARRAQUER SINGLE USE MICROKERATOME
K003594 · Moria, Inc. · Mar 2001
CARRIAZO BARRAQUER II MICROKERATOME
K002191 · Moria, Inc. · Oct 2000
MILLENIUM MICROKERATOME, MODEL IMD-001
K992687 · Industrial & Medical Design, Inc. · Sep 1999
K022560 · M2 SINGLE USE MICROKERTOME
Download PDF FDA Summary Moria SA