Cleared Traditional

M2 COMPATIBLE MICROKERATOME BLADE (K033457) - FDA 510(k) Clearance

Class I Ophthalmic device.

K033457 · Micro Specialties, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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.

Device Classification

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.