Cleared Special

K040204 - ZYOPTIX XP MICROKERATOME

K040204 is an FDA 510(k) clearance for ZYOPTIX XP 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 53-day FDA review.

K040204 · Bausch & Lomb, Inc. · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2004
Decision
53d
Days
Class 1
Risk

K040204 is an FDA 510(k) clearance for the ZYOPTIX XP MICROKERATOME. Classified as Keratome, Ac-powered (product code HNO), Class I - General Controls.

Submitted by Bausch & Lomb, Inc. (Rochester, US). The FDA issued a Cleared decision on March 22, 2004 after a review of 53 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 - K040204

510(k) Number K040204 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 29, 2004
Decision Date March 22, 2004
Days to Decision 53 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
57d faster than avg
Panel avg: 110d · This submission: 53d
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 K040204.
M3 MICROKERATOME
K032836 · Moria SA · Jun 2004
M2 COMPATIBLE MICROKERATOME BLADE
K033457 · Micro Specialties, Inc. · May 2004
PRIZM KERATOME BLADE, MODEL MK8512M2
K033236 · Surgin Surgical Instrumentation, Inc. · Mar 2004
PRIZM KERATOME BLADE (B.D. MODEL), MODEL MK8530BD
K033182 · Surgin Surgical Instrumentation, Inc. · Jan 2004
MED-LOGICS, MODEL ML7090
K033293 · Med-Logics, Inc. · Jan 2004
MODIFICATION TO CIBA VISION CENTURION SES SPIKERATOME
K032978 · Ciba Vision Corporation · Oct 2003
K040204 · ZYOPTIX XP MICROKERATOME
Download PDF FDA Summary Bausch & Lomb, Inc.