Cleared Special

K021640 - HANSATOME EXCELLUS MICROKERATOME

K021640 is an FDA 510(k) clearance for HANSATOME EXCELLUS MICROKERATOME, manufactured by Bausch & Lomb, Inc.. The device is a Class 1 Ophthalmic device with product code HNO cleared through the Special 510(k) pathway after a 30-day FDA review.

K021640 · Bausch & Lomb, Inc. · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2002
Decision
30d
Days
Class 1
Risk

K021640 is an FDA 510(k) clearance for the HANSATOME EXCELLUS MICROKERATOME. Classified as Keratome, Ac-powered (product code HNO), Class I - General Controls.

Submitted by Bausch & Lomb, Inc. (St. Louis, US). The FDA issued a Cleared decision on June 19, 2002 after a review of 30 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K021640

510(k) Number K021640 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 2002
Decision Date June 19, 2002
Days to Decision 30 days
Submission Type Special
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
80d faster than avg
Panel avg: 110d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

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 82
Devices cleared under the same product code (HNO) and FDA review panel - the closest regulatory comparables to K021640.
MED-LOGICS MICROKERATOME BLADE, MODEL 7050CLB
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MED-LOGICS MICROKERATOME BLADE, MODEL 7020CLB
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DISPOSABLE N-PE MICROKERATOME BLADES
K022205 · Oasis Medical, Inc. · Oct 2002
BLADEWORKS MICROKERATOME BLADE, MODEL 7061
K020079 · Blade Works, Inc. · Apr 2002
VISTITOME 20-10 MICROKERATOME
K014000 · Biovision AG · Mar 2002
MB 103 MILLENNIUM BLADES
K011833 · Millennium Biomedical, Inc. · Feb 2002
K021640 · HANSATOME EXCELLUS MICROKERATOME
Download PDF FDA Summary Bausch & Lomb, Inc.