Cleared Traditional

K032836 - M3 MICROKERATOME

K032836 is an FDA 510(k) clearance for M3 MICROKERATOME, manufactured by Moria SA. The device is a Class 1 Ophthalmic device with product code HNO cleared through the Traditional 510(k) pathway after a 281-day FDA review.

K032836 · Moria SA · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2004
Decision
281d
Days
Class 1
Risk

K032836 is an FDA 510(k) clearance for the M3 MICROKERATOME. Classified as Keratome, Ac-powered (product code HNO), Class I - General Controls.

Submitted by Moria SA (Antony, FR). The FDA issued a Cleared decision on June 18, 2004 after a review of 281 days - an extended review 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: 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 SA devices

FDA 510(k) Submission Details - K032836

510(k) Number K032836 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 2003
Decision Date June 18, 2004
Days to Decision 281 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
171d slower than avg
Panel avg: 110d · This submission: 281d
Pathway characteristics
Predicate-based equivalence.

HNO Device Classification - Class 1, General Controls

Product Code HNO Keratome, Ac-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 - HNO Keratome, Ac-powered

All 57
Devices cleared under the same product code (HNO) and FDA review panel - the closest regulatory comparables to K032836.
CENTURION SES EPIKERATOME
K042810 · Norwood Abbey , Ltd. · Oct 2004
MB 105 MILLENNIUM BLADES
K041110 · Millennium Biomedical, Inc. · Oct 2004
EPITOME SYSTEM
K041206 · Gebauer Medizintechnik GmbH · Sep 2004
PRIZM KERATOME BLADE, MODEL MK8512M2
K033236 · Surgin Surgical Instrumentation, Inc. · Mar 2004
ZYOPTIX XP MICROKERATOME
K040204 · Bausch & Lomb, Inc. · Mar 2004
PRIZM KERATOME BLADE (B.D. MODEL), MODEL MK8530BD
K033182 · Surgin Surgical Instrumentation, Inc. · Jan 2004