Cleared Traditional

K042083 - MODIFICATION TO VISITOME 20-10 MICROKERATOME

K042083 is an FDA 510(k) clearance for MODIFICATION TO VISITOME 20-10 MICROKER..., 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 105-day FDA review.

K042083 · Biovision AG · Ophthalmic device
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Nov 2004
Decision
105d
Days
Class 1
Risk

K042083 is an FDA 510(k) clearance for the MODIFICATION TO VISITOME 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 November 16, 2004 after a review of 105 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 - K042083

510(k) Number K042083 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 03, 2004
Decision Date November 16, 2004
Days to Decision 105 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
5d faster than avg
Panel avg: 110d · This submission: 105d
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
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