Cleared Traditional

K981071 - ML MICROKERATOME

K981071 is an FDA 510(k) clearance for ML MICROKERATOME, manufactured by Med-Logics, Inc.. The device is a Class 1 Ophthalmic device with product code HNO cleared through the Traditional 510(k) pathway after a 121-day FDA review.

K981071 · Med-Logics, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1998
Decision
121d
Days
Class 1
Risk

K981071 is an FDA 510(k) clearance for the ML MICROKERATOME. Classified as Keratome, Ac-powered (product code HNO), Class I - General Controls.

Submitted by Med-Logics, Inc. (Laguna Niguel, US). The FDA issued a Cleared decision on July 23, 1998 after a review of 121 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 Med-Logics, Inc. devices

FDA 510(k) Submission Details - K981071

510(k) Number K981071 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 24, 1998
Decision Date July 23, 1998
Days to Decision 121 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
11d slower than avg
Panel avg: 110d · This submission: 121d
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 K981071.
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
KERATOME BLADE, CHIROM MODEL ALK 500500
K980508 · Micro Specialties, Inc. · May 1998
KERATOME BLADE (135 MICRON, MODEL 300135), (160 MICRON, MODEL 300160), (200 MICRON, MODEL 30020)
K980510 · Micro Specialties, Inc. · May 1998
SCMD-1000
K980985 · Howard Instruments, Inc. · May 1998