Cleared Traditional

K983317 - BARRON MICROKERATOME SYSTEM, MODEL B2000

K983317 is an FDA 510(k) clearance for BARRON MICROKERATOME SYSTEM, manufactured by Barron Precision Instruments, LLC. The device is a Class 1 Ophthalmic device with product code HNO cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K983317 · Barron Precision Instruments, LLC · Ophthalmic device
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Dec 1998
Decision
72d
Days
Class 1
Risk

K983317 is an FDA 510(k) clearance for the BARRON MICROKERATOME SYSTEM, MODEL B2000. Classified as Keratome, Ac-powered (product code HNO), Class I - General Controls.

Submitted by Barron Precision Instruments, LLC (Grand Blanc, US). The FDA issued a Cleared decision on December 2, 1998 after a review of 72 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.

View all Barron Precision Instruments, LLC devices

FDA 510(k) Submission Details - K983317

510(k) Number K983317 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 21, 1998
Decision Date December 02, 1998
Days to Decision 72 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
38d faster than avg
Panel avg: 110d · This submission: 72d
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 K983317.
KERAVISION VACUUM RING SYSTEM
K984540 · Keravision, Inc. · Apr 1999
SUMMIT KRUMEICH-BARRAQUER MICROKERATOME
K980675 · Summit Technology, Inc. · Dec 1998
MICRATOME MS7000 -ADVANCED CORNEAL/REFRACTIVE INSTRUMENTATION (ACRI)
K981554 · Micra Instruments , Ltd. · Dec 1998
ONE UP DISPOSABLE KERATOME HEAD
K981742 · Moria, Inc. · Aug 1998
FLAPMAKER DISPOSABLE MICROKERATOME
K981155 · Hawken Industries · Aug 1998
ML MICROKERATOME
K981071 · Med-Logics, Inc. · Jul 1998