Cleared Special

K032297 - DISPOSABLE N-PE MICKROKERATOME BLADES

K032297 is an FDA 510(k) clearance for DISPOSABLE N-PE MICKROKERATOME BLADES, manufactured by Oasis Medical, Inc.. The device is a Class 1 Ophthalmic device with product code HNO cleared through the Special 510(k) pathway after a 32-day FDA review.

K032297 · Oasis Medical, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2003
Decision
32d
Days
Class 1
Risk

K032297 is an FDA 510(k) clearance for the DISPOSABLE N-PE MICKROKERATOME BLADES. Classified as Keratome, Ac-powered (product code HNO), Class I - General Controls.

Submitted by Oasis Medical, Inc. (Glendora, US). The FDA issued a Cleared decision on August 26, 2003 after a review of 32 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 Oasis Medical, Inc. devices

FDA 510(k) Submission Details - K032297

510(k) Number K032297 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 2003
Decision Date August 26, 2003
Days to Decision 32 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
78d faster than avg
Panel avg: 110d · This submission: 32d
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 19
Devices cleared under the same product code (HNO) and FDA review panel - the closest regulatory comparables to K032297.
ZYOPTIX XP MICROKERATOME
K040204 · Bausch & Lomb, Inc. · Mar 2004
PRIZM KERATOME BLADE (B.D. MODEL), MODEL MK8530BD
K033182 · Surgin Surgical Instrumentation, Inc. · Jan 2004
MODIFICATION TO CIBA VISION CENTURION SES SPIKERATOME
K032978 · Ciba Vision Corporation · Oct 2003
CENTURION SES EPIKERATOME
K031735 · Ciba Vision Corporation · Aug 2003
HANSATOME EXCELLUS MICROKERATOME
K021640 · Bausch & Lomb, Inc. · Jun 2002
PRIZM BLADE (MORIA MODEL) LSK / MK8510LSK
K011195 · Surgin Surgical Instrumentation, Inc. · Nov 2001