Cleared Special

HANSATOME EXCELLUS MICROKERATOME (K021640) - FDA 510(k) Clearance

Class I Ophthalmic device.

K021640 · Bausch & Lomb, Inc. · Ophthalmic device
Download Printable Device Report (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.

View all Bausch & Lomb, Inc. devices

Submission Details

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
Regulatory Context
Review time vs. panel average
80d faster than avg
Panel avg: 110d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

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.