Cleared Traditional

K010260 - HANSATOME MICROKERATOME

K010260 is the FDA 510(k) clearance for HANSATOME MICROKERATOME by Bausch & Lomb, Inc.. It is a Class 1 Ophthalmic device (product code HNO) cleared through the Traditional 510(k) pathway after a 88-day FDA review.

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
Combination Product No
PCCP Authorized No
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.

Regulatory Peers - HNO Keratome, Ac-powered

All 8
Devices cleared under the same product code (HNO) and FDA review panel - the closest regulatory comparables to K010260.
ZYOPTIX XP EPI SEPARATOR SYSTEM
K062465 · Bausch & Lomb, Inc. · Sep 2006
ZYOPTIX XP MICROKERATOME
K040204 · Bausch & Lomb, Inc. · Mar 2004
HANSATOME EXCELLUS MICROKERATOME
K021640 · Bausch & Lomb, Inc. · Jun 2002
MICROKERATOME, MODEL MK-2000
K990900 · Nidek, Inc. · Sep 1999
QUALITATIVE KERATOMETER M823 WITH POWER SUPPLY
K911062 · Storz Instrument Co. · May 1991
STORZ DRAEGER ROTOR KERATOME
K904845 · Storz Instrument Co. · Jan 1991