Cleared Traditional

K853499 - MICRON-SCOPE

K853499 is the FDA 510(k) clearance for MICRON-SCOPE by Magnum Diamond, Inc.. It is a Class 1 Ophthalmic device (product code HNN) cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K853499 · Magnum Diamond, Inc. · Ophthalmic device
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Sep 1985
Decision
35d
Days
Class 1
Risk

K853499 is an FDA 510(k) clearance for the MICRON-SCOPE. Classified as Knife, Ophthalmic (product code HNN), Class I - General Controls.

Submitted by Magnum Diamond, Inc. (San Antonio, US). The FDA issued a Cleared decision on September 24, 1985 after a review of 35 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4350 - 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 Magnum Diamond, Inc. devices

Submission Details

510(k) Number K853499 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 20, 1985
Decision Date September 24, 1985
Days to Decision 35 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
75d faster than avg
Panel avg: 110d · This submission: 35d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HNN Knife, Ophthalmic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.4350
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 - HNN Knife, Ophthalmic

All 21
Devices cleared under the same product code (HNN) and FDA review panel - the closest regulatory comparables to K853499.
STORZ E9040 & E9046 DIAMOND KNIVES
K855050 · Storz Instrument Co. · Mar 1986
SMARTKNIFE SYSTEM
K853063 · CooperVision, Inc. · Nov 1985
STORZ DIAMOND KNIFE
K853403 · Storz Instrument Co. · Nov 1985
37-200 TO 37-246 VARIOUS OPHTHALMOLOGY SCALPELS/KN
K851790 · Artiberia · May 1985
CATARACT TRAY
K842647 · Deroyal Industries, Inc. · May 1985
MICRA DIAMOND KNIFE MICRA ADJUSTABLE KNIFE
K844553 · Codman & Shurtleff, Inc. · Dec 1984