Cleared Traditional

K003594 - CARRIAZO BARRAQUER SINGLE USE MICROKERATOME

K003594 is an FDA 510(k) clearance for CARRIAZO BARRAQUER SINGLE USE MICROKERATOME, manufactured by Moria, Inc.. The device is a Class 1 Ophthalmic device with product code HMY cleared through the Traditional 510(k) pathway after a 108-day FDA review.

K003594 · Moria, Inc. · Ophthalmic device
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Mar 2001
Decision
108d
Days
Class 1
Risk

K003594 is an FDA 510(k) clearance for the CARRIAZO BARRAQUER SINGLE USE MICROKERATOME. Classified as Keratome, Battery-powered (product code HMY), Class I - General Controls.

Submitted by Moria, Inc. (Antony, FR). The FDA issued a Cleared decision on March 9, 2001 after a review of 108 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

View all Moria, Inc. devices

FDA 510(k) Submission Details - K003594

510(k) Number K003594 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 2000
Decision Date March 09, 2001
Days to Decision 108 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
2d faster than avg
Panel avg: 110d · This submission: 108d
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 7
Devices cleared under the same product code (HMY) and FDA review panel - the closest regulatory comparables to K003594.
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
KERATOME SYSTEM, MODEL K3000
K984537 · Insight Technologies Instruments, LLC · May 1999
CARRIAZO BARRAQUER MICROKERATOME
K981741 · Moria, Inc. · Jul 1998
KERATOME SYSTEM
K974243 · Insight Technologies Instruments, LLC · Jan 1998
VISI-DRAPE OPHTHALMIC DRAPES
K902857 · Visitec Co. · Jul 1990