Cleared Traditional

K014000 - VISTITOME 20-10 MICROKERATOME

K014000 is an FDA 510(k) clearance for VISTITOME 20-10 MICROKERATOME, manufactured by Biovision AG. The device is a Class 1 Ophthalmic device with product code HNO cleared through the Traditional 510(k) pathway after a 97-day FDA review.

K014000 · Biovision AG · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2002
Decision
97d
Days
Class 1
Risk

K014000 is an FDA 510(k) clearance for the VISTITOME 20-10 MICROKERATOME. Classified as Keratome, Ac-powered (product code HNO), Class I - General Controls.

Submitted by Biovision AG (Irvine, US). The FDA issued a Cleared decision on March 11, 2002 after a review of 97 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

View all Biovision AG devices

FDA 510(k) Submission Details - K014000

510(k) Number K014000 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 2001
Decision Date March 11, 2002
Days to Decision 97 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
13d faster than avg
Panel avg: 110d · This submission: 97d
Pathway characteristics
Predicate-based equivalence.

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 50
Devices cleared under the same product code (HNO) and FDA review panel - the closest regulatory comparables to K014000.
DISPOSABLE M2-PE MICROKERATOME BLADES
K030401 · Oasis Medical, Inc. · Jun 2003
DISPOSABLE N-PE MICROKERATOME BLADES
K022205 · Oasis Medical, Inc. · Oct 2002
HANSATOME EXCELLUS MICROKERATOME
K021640 · Bausch & Lomb, Inc. · Jun 2002
PRIZM BLADE (MORIA MODEL) LSK / MK8510LSK
K011195 · Surgin Surgical Instrumentation, Inc. · Nov 2001
HANSATOME MICROKERATOME
K010260 · Bausch & Lomb, Inc. · Apr 2001
DISPOSABLE CB-PE MICROKERATOME BLADES
K003820 · Oasis Medical, Inc. · Mar 2001