Cleared Traditional

BLADEWORKS MICROKERATOME BLADE, MODEL 7061 (K020079) - FDA 510(k) Clearance

Class I Ophthalmic device.

K020079 · Blade Works, Inc. · Ophthalmic device
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Apr 2002
Decision
99d
Days
Class 1
Risk

K020079 is an FDA 510(k) clearance for the BLADEWORKS MICROKERATOME BLADE, MODEL 7061. Classified as Keratome, Ac-powered (product code HNO), Class I - General Controls.

Submitted by Blade Works, Inc. (San Marcos, US). The FDA issued a Cleared decision on April 19, 2002 after a review of 99 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 Blade Works, Inc. devices

Submission Details

510(k) Number K020079 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 10, 2002
Decision Date April 19, 2002
Days to Decision 99 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
11d faster than avg
Panel avg: 110d · This submission: 99d
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.