Cleared Traditional

K033457 - M2 COMPATIBLE MICROKERATOME BLADE

K033457 is an FDA 510(k) clearance for M2 COMPATIBLE MICROKERATOME BLADE, manufactured by Micro Specialties, Inc.. The device is a Class 1 Ophthalmic device with product code HNO cleared through the Traditional 510(k) pathway after a 208-day FDA review.

K033457 · Micro Specialties, Inc. · Ophthalmic device
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May 2004
Decision
208d
Days
Class 1
Risk

K033457 is an FDA 510(k) clearance for the M2 COMPATIBLE MICROKERATOME BLADE. Classified as Keratome, Ac-powered (product code HNO), Class I - General Controls.

Submitted by Micro Specialties, Inc. (Milford, US). The FDA issued a Cleared decision on May 25, 2004 after a review of 208 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 Micro Specialties, Inc. devices

FDA 510(k) Submission Details - K033457

510(k) Number K033457 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 30, 2003
Decision Date May 25, 2004
Days to Decision 208 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
98d slower than avg
Panel avg: 110d · This submission: 208d
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 43
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