Cleared Traditional

K981742 - ONE UP DISPOSABLE KERATOME HEAD

K981742 is an FDA 510(k) clearance for ONE UP DISPOSABLE KERATOME HEAD, manufactured by Moria, Inc.. The device is a Class 1 Ophthalmic device with product code HNO cleared through the Traditional 510(k) pathway after a 99-day FDA review.

K981742 · Moria, Inc. · Ophthalmic device
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Aug 1998
Decision
99d
Days
Class 1
Risk

K981742 is an FDA 510(k) clearance for the ONE UP DISPOSABLE KERATOME HEAD. Classified as Keratome, Ac-powered (product code HNO), Class I - General Controls.

Submitted by Moria, Inc. (Antony, FR). The FDA issued a Cleared decision on August 25, 1998 after a review of 99 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 - K981742

510(k) Number K981742 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 1998
Decision Date August 25, 1998
Days to Decision 99 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
11d faster than avg
Panel avg: 110d · This submission: 99d
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 41
Devices cleared under the same product code (HNO) and FDA review panel - the closest regulatory comparables to K981742.
SUMMIT KRUMEICH-BARRAQUER MICROKERATOME
K980675 · Summit Technology, Inc. · Dec 1998
MICRATOME MS7000 -ADVANCED CORNEAL/REFRACTIVE INSTRUMENTATION (ACRI)
K981554 · Micra Instruments , Ltd. · Dec 1998
BARRON MICROKERATOME SYSTEM, MODEL B2000
K983317 · Barron Precision Instruments, LLC · Dec 1998
FLAPMAKER DISPOSABLE MICROKERATOME
K981155 · Hawken Industries · Aug 1998
ML MICROKERATOME
K981071 · Med-Logics, Inc. · Jul 1998
KERATOME BLADE, CHIROM MODEL ALK 500500
K980508 · Micro Specialties, Inc. · May 1998