Cleared Traditional

HANSATOME MICROKERATOME (K010260) - FDA 510(k) Clearance

Class I Ophthalmic device.

K010260 · Bausch & Lomb, Inc. · Ophthalmic device
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Apr 2001
Decision
88d
Days
Class 1
Risk

K010260 is an FDA 510(k) clearance for the HANSATOME MICROKERATOME. Classified as Keratome, Ac-powered (product code HNO), Class I - General Controls.

Submitted by Bausch & Lomb, Inc. (Irvine, US). The FDA issued a Cleared decision on April 27, 2001 after a review of 88 days - a notably fast clearance 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: 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 Bausch & Lomb, Inc. devices

Submission Details

510(k) Number K010260 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 29, 2001
Decision Date April 27, 2001
Days to Decision 88 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
22d faster than avg
Panel avg: 110d · This submission: 88d
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.