Cleared Traditional

K984273 - FOCUS DAILIES VISITINT (NELFILCON A) ON...

K984273 is the FDA 510(k) clearance for FOCUS DAILIES VISITINT (NELFILCON A) ON... by Ciba Vision Corporation. It is a Class 2 Ophthalmic device (product code MVN) cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K984273 · Ciba Vision Corporation · Ophthalmic device
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Jan 1999
Decision
56d
Days
Class 2
Risk

K984273 is an FDA 510(k) clearance for the FOCUS DAILIES VISITINT (NELFILCON A) ONE-DAY CONTACT LENS. Classified as Lens, Contact, (disposable) (product code MVN), Class II - Special Controls.

Submitted by Ciba Vision Corporation (Duluth, US). The FDA issued a Cleared decision on January 25, 1999 after a review of 56 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.5925 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Ciba Vision Corporation devices

Submission Details

510(k) Number K984273 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 30, 1998
Decision Date January 25, 1999
Days to Decision 56 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
54d faster than avg
Panel avg: 110d · This submission: 56d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MVN Lens, Contact, (disposable)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.5925
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ophthalmic devices follow this clearance model.

Regulatory Peers - MVN Lens, Contact, (disposable)

All 7
Devices cleared under the same product code (MVN) and FDA review panel - the closest regulatory comparables to K984273.
PROCLEAR (OMAFILCON A) DAILY DISPOSABLE/DAILY WEAR SOFT CONTACT LENS
K061948 · CooperVision, Inc. · Nov 2006
BAUSCH & LOMB SOFLENS ONE DAY DISPOSABLE (HILAFILCON A) VISIBILITY TINTED CONTACT
K011718 · Bausch & Lomb, Inc. · Jul 2001
METHAFILCON A SOFT HYDROPHILIC CONTACT LENSES, FREQUENCY 55, FREQUENCY 55 UV (TO BE MARKETED YR. 2000), FREQUENCY 55 ASP
K993252 · CooperVision, Inc. · Nov 1999