Cleared Special

K010636 - FOCUS DAILIES (NELFILCON A) ONE-DAY SOFT CONTACT LENSES, FOCUS DAILIES PROGRESSIVES (NELFILCON A) ONE-DAY SOFT CONTACT

K010636 is an FDA 510(k) clearance for FOCUS DAILIES (NELFILCON A) ONE-DAY SOF..., manufactured by Ciba Vision Corporation. The device is a Class 2 Ophthalmic device with product code MVN cleared through the Special 510(k) pathway after a 18-day FDA review.

K010636 · Ciba Vision Corporation · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2001
Decision
18d
Days
Class 2
Risk

K010636 is an FDA 510(k) clearance for the FOCUS DAILIES (NELFILCON A) ONE-DAY SOFT CONTACT LENSES, FOCUS DAILIES PROGRE.... 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 March 23, 2001 after a review of 18 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. 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 - K010636

510(k) Number K010636 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 05, 2001
Decision Date March 23, 2001
Days to Decision 18 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
92d faster than avg
Panel avg: 110d · This submission: 18d
Pathway characteristics
Modification to existing cleared device.

MVN Device Classification - Class 2, Special Controls

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 25
Devices cleared under the same product code (MVN) and FDA review panel - the closest regulatory comparables to K010636.
FOCUS DAILIES, FOCUS DAILIES TORIC AND FOCUS DAILIES PROGRESSIVES ONE-DAY SOFT CONTACT LENSES
K033701 · Ciba Vision Corporation · Dec 2003
BIOMEDICS 52 (OCUFILCON B) UV BLOCKING DAILY WEAR SOFT CONTACT LENS
K020389 · Ocular Sciences · Jun 2002
BAUSCH & LOMB SOFLENS ONE DAY DISPOSABLE (HILAFILCON A) VISIBILITY TINTED CONTACT
K011718 · Bausch & Lomb, Inc. · Jul 2001
FOCUS DAILIES PROGRESSIVES
K003826 · Ciba Vision Corporation · Mar 2001
FOCUS DAILIES (NELFILCON A) ONE-DAY CONTACT LENSES
K003586 · Ciba-Geigy Corp. · Feb 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
K010636 · FOCUS DAILIES (NELFILCON A) ONE-DAY SOFT CONTACT LENSES, FOCUS DAILIES PROGRESSIVES (NELFILCON A) ONE-DAY SOFT CONTACT
Download PDF FDA Summary Ciba Vision Corporati…