Cleared Traditional

K962661 - ML MICROKERATOME BLADE

K962661 is an FDA 510(k) clearance for ML MICROKERATOME BLADE, 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 154-day FDA review.

K962661 · Med-Logics, Inc. · Ophthalmic device
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Dec 1996
Decision
154d
Days
Class 1
Risk

K962661 is an FDA 510(k) clearance for the ML MICROKERATOME BLADE. Classified as Keratome, Ac-powered (product code HNO), Class I - General Controls.

Submitted by Med-Logics, Inc. (Temple City, US). The FDA issued a Cleared decision on December 9, 1996 after a review of 154 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 Med-Logics, Inc. devices

FDA 510(k) Submission Details - K962661

510(k) Number K962661 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 08, 1996
Decision Date December 09, 1996
Days to Decision 154 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
44d slower than avg
Panel avg: 110d · This submission: 154d
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 K962661.
CBALK-1000 BLADE
K972727 · Howard Instruments, Inc. · Oct 1997
INNOVATOME MICROKERATOME
K973294 · Innovative Optics, Inc. · Oct 1997
PLANCON MICROLAMELLAR KERATOME (SINGLE PIECE KERATOME HEAD WITH ACCESSORIES)
K970377 · Plancon Instruments · Mar 1997
AUTOMATIC CORNEAL SHAPER SURGICAL INSTRUMENT
K941550 · Chiron Vision Corp. · Nov 1994
QUALITATIVE KERATOMETER M823 WITH POWER SUPPLY
K911062 · Storz Instrument Co. · May 1991
STORZ DRAEGER ROTOR KERATOME
K904845 · Storz Instrument Co. · Jan 1991