Cleared Traditional

K981554 - MICRATOME MS7000 -ADVANCED CORNEAL/REFRACTIVE INSTRUMENTATION (ACRI)

K981554 is an FDA 510(k) clearance for MICRATOME MS7000 -ADVANCED CORNEAL/REFR..., manufactured by Micra Instruments , Ltd.. The device is a Class 1 Ophthalmic device with product code HNO cleared through the Traditional 510(k) pathway after a 235-day FDA review.

K981554 · Micra Instruments , Ltd. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1998
Decision
235d
Days
Class 1
Risk

K981554 is an FDA 510(k) clearance for the MICRATOME MS7000 -ADVANCED CORNEAL/REFRACTIVE INSTRUMENTATION (ACRI). Classified as Keratome, Ac-powered (product code HNO), Class I - General Controls.

Submitted by Micra Instruments , Ltd. (Luton, Bedfordshire, GB). The FDA issued a Cleared decision on December 22, 1998 after a review of 235 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 Micra Instruments , Ltd. devices

FDA 510(k) Submission Details - K981554

510(k) Number K981554 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 1998
Decision Date December 22, 1998
Days to Decision 235 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
125d slower than avg
Panel avg: 110d · This submission: 235d
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 42
Devices cleared under the same product code (HNO) and FDA review panel - the closest regulatory comparables to K981554.
MICROKERATOME, MODEL MK-2000
K990900 · Nidek, Inc. · Sep 1999
KERAVISION VACUUM RING SYSTEM
K984540 · Keravision, Inc. · Apr 1999
SUMMIT KRUMEICH-BARRAQUER MICROKERATOME
K980675 · Summit Technology, Inc. · Dec 1998
BARRON MICROKERATOME SYSTEM, MODEL B2000
K983317 · Barron Precision Instruments, LLC · Dec 1998
ONE UP DISPOSABLE KERATOME HEAD
K981742 · Moria, Inc. · Aug 1998
FLAPMAKER DISPOSABLE MICROKERATOME
K981155 · Hawken Industries · Aug 1998